Company
Airway Management Inc
Apex Dental Sleep Lab
Dream Systems Dental
Sleep Lab DynaFlex Great Lakes Dental
Technologies Luco Hybrid OSA Inc Open Airway
Dental Solutions Ltd Open Airway
Dental Solutions Ltd Panthera Dental Panthera Dental ProSomnus Sleep
Technologies ProSomnus Sleep
Technologies ProSomnus Sleep
Technologies SICAT GmbH & Co KG Slow Wave Inc SomnoMed Tomed GmbH Appliance flexTAP EMA Serena Nylon OASYS Oral / Nasal Airway
System (Optional Tongue
Repositioning Buttons) DynaFlex Herbst Nylon Sleep Herbst The Luco Hybrid OSA
Appliance O2Vent Optima O2Vent Optima Mini Panthera D-SAD Classic Panthera D-SAD X3 ProSomnus EVO ProSomnus EVO [PH] ProSomnus EVO SELECT OPTISLEEP Slow Wave DS8 SomnoMed Herbst Advance Elite SomnoGuard SP Pro Website www.tapintosleep.com www.apexsleep.com www.dreamsystemdentallab.com www.dynaflex.com/dental-sleep-medicine www.greatlakesdentaltech.com www.lucohybridosa.com openairway.com openairway.com www.pantherasleep.com www.pantherasleep.com www.prosomnus.com www.prosomnus.com www.prosomnus.com www.optisleep.com www.slowwave.net somnomed.co/en/dentists/products www.tomed.com Warranty (days) flexTAP 730 365 1,095 730 365 1,095 1,095 1,095 1,095 1,095.75 1,095 (+730 for Medicare patients) 1,095.75 730 1,095 1,095 730 Indications Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring, Bruxism Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Materials Thermal Acrylic, Laminate, Nylon, no metal parts Nylon, Biocompatible
Nylon Biocompatible Polymer, Cobalt-Chromium Alloys, Stainless Steel, Hard Acrylic, Laminate, Thermal Acrylic Biocompatible Polymer, Stainless Steel, Hard Acrylic Nylon Cobalt Chromium Alloys, Stainless Steel, Hard Acrylic 3D printed with durable nylon 3D printed with durable nylon Biocompatible Polymer, Nylon Biocompatible Polymer, Nylon Biocompatible Polymer, Medical grade class VI Biocompatible Polymer, Stainless Steel, Medical grade class VI Biocompatible Polymer, Medical grade class VI Biocompatible
Polymer, Hard Acrylic Hard Acrylic, BioMed Clear Biocompatible
Polymer, Cobalt-Chromium Alloys, Stainless Steel, Hard Acrylic Laminate, Hard Acrylic, Stainless Steel PDAC Verified Yes No Yes (Only OASYS Herbst w/Nasal Dilators & Tongue Lifters) Yes Yes Yes Yes Yes Yes Yes No Yes No No Yes Yes No How Does the Oral
Appliance Work? FlexTAP advances the lower jaw with a single point midline advancement. Self-titratable adjustments in 1/3 mm increments aid in easier, faster, and better treatment outcomes. Uses Frantz Design Patent Elastic Mandibular Advancement straps that have been used to treat mild to moderate sleep apnea for over 25 years to position the jaw forward while managing comfort and durability with biocompatible nylon. The Oasys Simplicity provides mandibular advancement. The standard Oasys with Nasal Dilators improves nasal breathing and adding Tongue Lifters improves forward tongue positioning. Protrudes the mandible forward to open the airway. Mandibular position is set to open the airway and hold this position while sleeping. For OSA, advances the tongue and mandible forward opening the airway. For sleep-related bruxism, the patented forward bite reduces or eliminates the sleep-related bruxism as well as the associated increases in heart rate, blood pressure, and cardiovascular risk. O2Vent Optima has two mechanisms of action that add stability to the airway. 1. A mechanism of advancing the jaw forward encouraging a more open airway. 2. Incorporates an airway channel that further stabilizes the airway. O2Vent Optima has two mechanisms of action that add stability to the airway. 1. A mechanism of advancing the jaw forward encouraging a more open airway. 2. Incorporates an airway channel that further stabilizes the airway. Traction appliance design, in line with the occlusal plane, promoting nasal breathing, minimizing stress on the TMJ and allowing more space for the tongue. A single set of upper and lower splints are connected through a patented rod titration system. Low profile and lightweight dorsal fin appliance. Maximizes tongue space and avoids soft tissue contact. A single set of durable upper and lower splints are adjusted using an interchangeable clip system. ProSomnus EVO uses vertically mated buccal posts to advance and hold the mandible forward to open the airway. The ProSomnus [PH] uses a continuous advancement protocol. Upper arch connects via Herbst Arm to lower arch with an adjustment nut. ProSomnus EVO SELECT uses vertically mated buccal posts to advance and hold the mandible forward to open the airway. The airway is kept open by protrusion of the mandible with a 2-part appliance. It allows for lateral movement and mouth opening. Incorporates a vertical opening and makes more room for the tongue. Also stimulates your brain to naturally migrate the tongue forward during sleep. The device functions as a mandibular repositioner, which acts to increase the patient’s pharyngeal space during sleep. A 2-piece, adjustable mandibular advancement device with a connector on each side, it repositions the lower jaw forward and so prevents collapse of the upper airway. Intraoral-Scan Impression Compatible Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Max Protrusion/
Max Retrusion/Adjustment Increment (mm) 17/
2/
0.333 9/
0/
1 15/
5/
1 5/
0.5/
16-1 4/
1
/<0.25 10/
2/
0.25 6/
2/
1 6/
2/
1 N/A/
N/A/
0.5 5/
-1/
0.5 unlimited/
customizable/
1 12/
-1/
0.1 unlimited/
customizable/
1 9/
9/
1 2/
2/
N/A (no adjustments needed) 8/
-1/
0.5 7/
3/
1 Upper-Lower Connection Connected. Connected. Not connected. Connected. Connected. Not connected. Connected. Connected. Connected. Not connected. Not connected. Connected. Not connected. Connected. Not connected. Connected. Connected. Custom Accessories Available Mouth Shield nasal breathing trainer, AM Aligner morning repositioner None Retention clasps, hooks & elastics, in combination with Invisalign Comes standard with hooks for elastics Advancement shims, ‘C’ cut shims, elastics, telescopic hardware Not required. Connector bands, biteforks. Connector bands, biteforks. Pairs of interchangeable elongation-proof rods allow for a titration range from 16 mm to 34 mm in 0.5 mm increments. Patented locking mechanism prevents rods from disengaging during sleep. Titration clips (allow adjustment from -1 mm to +5 mm in 0.5 mm increments). Monogram customization options. Monogram customization options. Monogram customization options. None. None. Distal wrap, breathing hole, Denti-Trac compliance recorder, edentulous. Straps, screws. Supporting Study tapintosleep.com/peer-reviewed-studies Not provided. Shrivastava D, Bixby JK,
Livornese DS, et al. Efficacy of
oral appliance therapy in the
treatment of severe OSA in
CPAP-resistant cases. Sleep
Vigilance. 2018. Not provided. Not provided. DOI: 10.4172/2325-9639.1000223, DOI: 10.4172/2325-9639.1000218, DOI: 10.4172/2325-9639.1000211 openairway.com/pages/clinical-resources openairway.com/pages/clinical-resources Not provided. Not provided. Mosca E, Remmers J. Precision vs traditional oral appliance therapy: A comparison of therapeutic efficacy. JDSM 10.2. Abstract #006. (https://aadsm.org/journal/abstracts_issue_102.php) Not provided. Not provided. Not provided. Not provided. Phillips CL, Grunstein RR, Darendeliler MA, et al. doi: 10.1164/rccm.201212-2223OC Not provided. Features A CAD/CAM process uses robotics, AI, and proprietary software to custom-make these nylon appliances from intraoral scans or physical impressions. High manufacturing precision, with numerous customization options and an exclusive polishing process. Durable and thin nylon. Unique applications with upper denture, minimal dentition upper or lower, nasal obstruction or resistance, in combination with Invisalign. CAD/CAM designed for precision. Allows lateral and vertical movement without disengaging the appliance. Made less than 1 mm thick, retains durability and retention while maintaining appropriate flexibility. The Luco Hybrid is the first and only FDA cleared treatment of sleep-related bruxism. The O2Vent Optima products are OADS’ latest offering in the O2Vent oral appliance range. The lower jaw can be moved forward to a comfortable range while also allowing the integrated airway channel to bypass nasal congestion and other areas of airway collapse, such as from the tongue, soft palate, and lateral walls. The O2Vent Optima Mini is a discreet, low-profile oral device that manages the upper airway for the treatment of mild to moderate obstructive sleep apnea (OSA) and snoring. The O2Vent Optima Mini’s design (without the airway extension) may benefit patients requiring enhanced lip-seal to avoid excess saliva build-up and/or dry lips. A CAD/CAM process uses robotics, AI, and proprietary software to custom-make these nylon appliances from intraoral scans or physical impressions. High manufacturing precision, with numerous customization options and an exclusive polishing process. A CAD/CAM process uses robotics, AI, and proprietary software to custom-make these nylon appliances from intraoral scans or physical impressions. High manufacturing precision, with numerous customization options and an exclusive polishing process. Incorporates advanced materials, manufacturing robotics, and AI to advance the treatment of OSA using a precision platform. In a controlled IRB study (2021), 100% of patients preferred EVO over previous devices and CPAP; 100% of providers would recommend EVO; and 100% of providers stated EVO was easy to deliver. Features MG6 technology. ProSomnus EVO [PH], FDA cleared and Medicare E0486 verified. EVO [PH] is the only dual arm advancement device with innovative materials, manufacturing robotics and artificial intelligence designed to provide a better experience for all patients. Engineered for performance, biocompatibility and the greatest comfort. A signature variation of the ProSomnus EVO device, EVO SELECT is optimized for patients who may benefit from a more compact, effective, and easy to use precision OAT medical device using the most innovative materials. Not provided. No need for morning repositioner. 3D printed. Accurate to within 1/100th of a mm. 100 day money back guaranteed. The SomnoDent Herbst Advance Elite is a Herbst-style appliance that is individually milled from one piece of pre-cured PMMA for greater flexural strength. All the patented strength improvements in the Herbst Advance are also found in the Herbst Advance Elite. SomnoMed will replace it for free if it breaks, no questions asked, for 3 years. The Herbst Advance Elite is only supplied with a Bflex soft inner liner for increased comfort and unsurpassed retention. Not provided.
Sleep Lab DynaFlex Great Lakes Dental
Technologies Luco Hybrid OSA Inc Open Airway
Dental Solutions Ltd Open Airway
Dental Solutions Ltd Panthera Dental Panthera Dental ProSomnus Sleep
Technologies ProSomnus Sleep
Technologies ProSomnus Sleep
Technologies SICAT GmbH & Co KG Slow Wave Inc SomnoMed Tomed GmbH Appliance flexTAP EMA Serena Nylon OASYS Oral / Nasal Airway
System (Optional Tongue
Repositioning Buttons) DynaFlex Herbst Nylon Sleep Herbst The Luco Hybrid OSA
Appliance O2Vent Optima O2Vent Optima Mini Panthera D-SAD Classic Panthera D-SAD X3 ProSomnus EVO ProSomnus EVO [PH] ProSomnus EVO SELECT OPTISLEEP Slow Wave DS8 SomnoMed Herbst Advance Elite SomnoGuard SP Pro Website www.tapintosleep.com www.apexsleep.com www.dreamsystemdentallab.com www.dynaflex.com/dental-sleep-medicine www.greatlakesdentaltech.com www.lucohybridosa.com openairway.com openairway.com www.pantherasleep.com www.pantherasleep.com www.prosomnus.com www.prosomnus.com www.prosomnus.com www.optisleep.com www.slowwave.net somnomed.co/en/dentists/products www.tomed.com Warranty (days) flexTAP 730 365 1,095 730 365 1,095 1,095 1,095 1,095 1,095.75 1,095 (+730 for Medicare patients) 1,095.75 730 1,095 1,095 730 Indications Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring, Bruxism Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Mild-Moderate OSA, Snoring Materials Thermal Acrylic, Laminate, Nylon, no metal parts Nylon, Biocompatible
Nylon Biocompatible Polymer, Cobalt-Chromium Alloys, Stainless Steel, Hard Acrylic, Laminate, Thermal Acrylic Biocompatible Polymer, Stainless Steel, Hard Acrylic Nylon Cobalt Chromium Alloys, Stainless Steel, Hard Acrylic 3D printed with durable nylon 3D printed with durable nylon Biocompatible Polymer, Nylon Biocompatible Polymer, Nylon Biocompatible Polymer, Medical grade class VI Biocompatible Polymer, Stainless Steel, Medical grade class VI Biocompatible Polymer, Medical grade class VI Biocompatible
Polymer, Hard Acrylic Hard Acrylic, BioMed Clear Biocompatible
Polymer, Cobalt-Chromium Alloys, Stainless Steel, Hard Acrylic Laminate, Hard Acrylic, Stainless Steel PDAC Verified Yes No Yes (Only OASYS Herbst w/Nasal Dilators & Tongue Lifters) Yes Yes Yes Yes Yes Yes Yes No Yes No No Yes Yes No How Does the Oral
Appliance Work? FlexTAP advances the lower jaw with a single point midline advancement. Self-titratable adjustments in 1/3 mm increments aid in easier, faster, and better treatment outcomes. Uses Frantz Design Patent Elastic Mandibular Advancement straps that have been used to treat mild to moderate sleep apnea for over 25 years to position the jaw forward while managing comfort and durability with biocompatible nylon. The Oasys Simplicity provides mandibular advancement. The standard Oasys with Nasal Dilators improves nasal breathing and adding Tongue Lifters improves forward tongue positioning. Protrudes the mandible forward to open the airway. Mandibular position is set to open the airway and hold this position while sleeping. For OSA, advances the tongue and mandible forward opening the airway. For sleep-related bruxism, the patented forward bite reduces or eliminates the sleep-related bruxism as well as the associated increases in heart rate, blood pressure, and cardiovascular risk. O2Vent Optima has two mechanisms of action that add stability to the airway. 1. A mechanism of advancing the jaw forward encouraging a more open airway. 2. Incorporates an airway channel that further stabilizes the airway. O2Vent Optima has two mechanisms of action that add stability to the airway. 1. A mechanism of advancing the jaw forward encouraging a more open airway. 2. Incorporates an airway channel that further stabilizes the airway. Traction appliance design, in line with the occlusal plane, promoting nasal breathing, minimizing stress on the TMJ and allowing more space for the tongue. A single set of upper and lower splints are connected through a patented rod titration system. Low profile and lightweight dorsal fin appliance. Maximizes tongue space and avoids soft tissue contact. A single set of durable upper and lower splints are adjusted using an interchangeable clip system. ProSomnus EVO uses vertically mated buccal posts to advance and hold the mandible forward to open the airway. The ProSomnus [PH] uses a continuous advancement protocol. Upper arch connects via Herbst Arm to lower arch with an adjustment nut. ProSomnus EVO SELECT uses vertically mated buccal posts to advance and hold the mandible forward to open the airway. The airway is kept open by protrusion of the mandible with a 2-part appliance. It allows for lateral movement and mouth opening. Incorporates a vertical opening and makes more room for the tongue. Also stimulates your brain to naturally migrate the tongue forward during sleep. The device functions as a mandibular repositioner, which acts to increase the patient’s pharyngeal space during sleep. A 2-piece, adjustable mandibular advancement device with a connector on each side, it repositions the lower jaw forward and so prevents collapse of the upper airway. Intraoral-Scan Impression Compatible Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Max Protrusion/
Max Retrusion/Adjustment Increment (mm) 17/
2/
0.333 9/
0/
1 15/
5/
1 5/
0.5/
16-1 4/
1
/<0.25 10/
2/
0.25 6/
2/
1 6/
2/
1 N/A/
N/A/
0.5 5/
-1/
0.5 unlimited/
customizable/
1 12/
-1/
0.1 unlimited/
customizable/
1 9/
9/
1 2/
2/
N/A (no adjustments needed) 8/
-1/
0.5 7/
3/
1 Upper-Lower Connection Connected. Connected. Not connected. Connected. Connected. Not connected. Connected. Connected. Connected. Not connected. Not connected. Connected. Not connected. Connected. Not connected. Connected. Connected. Custom Accessories Available Mouth Shield nasal breathing trainer, AM Aligner morning repositioner None Retention clasps, hooks & elastics, in combination with Invisalign Comes standard with hooks for elastics Advancement shims, ‘C’ cut shims, elastics, telescopic hardware Not required. Connector bands, biteforks. Connector bands, biteforks. Pairs of interchangeable elongation-proof rods allow for a titration range from 16 mm to 34 mm in 0.5 mm increments. Patented locking mechanism prevents rods from disengaging during sleep. Titration clips (allow adjustment from -1 mm to +5 mm in 0.5 mm increments). Monogram customization options. Monogram customization options. Monogram customization options. None. None. Distal wrap, breathing hole, Denti-Trac compliance recorder, edentulous. Straps, screws. Supporting Study tapintosleep.com/peer-reviewed-studies Not provided. Shrivastava D, Bixby JK,
Livornese DS, et al. Efficacy of
oral appliance therapy in the
treatment of severe OSA in
CPAP-resistant cases. Sleep
Vigilance. 2018. Not provided. Not provided. DOI: 10.4172/2325-9639.1000223, DOI: 10.4172/2325-9639.1000218, DOI: 10.4172/2325-9639.1000211 openairway.com/pages/clinical-resources openairway.com/pages/clinical-resources Not provided. Not provided. Mosca E, Remmers J. Precision vs traditional oral appliance therapy: A comparison of therapeutic efficacy. JDSM 10.2. Abstract #006. (https://aadsm.org/journal/abstracts_issue_102.php) Not provided. Not provided. Not provided. Not provided. Phillips CL, Grunstein RR, Darendeliler MA, et al. doi: 10.1164/rccm.201212-2223OC Not provided. Features A CAD/CAM process uses robotics, AI, and proprietary software to custom-make these nylon appliances from intraoral scans or physical impressions. High manufacturing precision, with numerous customization options and an exclusive polishing process. Durable and thin nylon. Unique applications with upper denture, minimal dentition upper or lower, nasal obstruction or resistance, in combination with Invisalign. CAD/CAM designed for precision. Allows lateral and vertical movement without disengaging the appliance. Made less than 1 mm thick, retains durability and retention while maintaining appropriate flexibility. The Luco Hybrid is the first and only FDA cleared treatment of sleep-related bruxism. The O2Vent Optima products are OADS’ latest offering in the O2Vent oral appliance range. The lower jaw can be moved forward to a comfortable range while also allowing the integrated airway channel to bypass nasal congestion and other areas of airway collapse, such as from the tongue, soft palate, and lateral walls. The O2Vent Optima Mini is a discreet, low-profile oral device that manages the upper airway for the treatment of mild to moderate obstructive sleep apnea (OSA) and snoring. The O2Vent Optima Mini’s design (without the airway extension) may benefit patients requiring enhanced lip-seal to avoid excess saliva build-up and/or dry lips. A CAD/CAM process uses robotics, AI, and proprietary software to custom-make these nylon appliances from intraoral scans or physical impressions. High manufacturing precision, with numerous customization options and an exclusive polishing process. A CAD/CAM process uses robotics, AI, and proprietary software to custom-make these nylon appliances from intraoral scans or physical impressions. High manufacturing precision, with numerous customization options and an exclusive polishing process. Incorporates advanced materials, manufacturing robotics, and AI to advance the treatment of OSA using a precision platform. In a controlled IRB study (2021), 100% of patients preferred EVO over previous devices and CPAP; 100% of providers would recommend EVO; and 100% of providers stated EVO was easy to deliver. Features MG6 technology. ProSomnus EVO [PH], FDA cleared and Medicare E0486 verified. EVO [PH] is the only dual arm advancement device with innovative materials, manufacturing robotics and artificial intelligence designed to provide a better experience for all patients. Engineered for performance, biocompatibility and the greatest comfort. A signature variation of the ProSomnus EVO device, EVO SELECT is optimized for patients who may benefit from a more compact, effective, and easy to use precision OAT medical device using the most innovative materials. Not provided. No need for morning repositioner. 3D printed. Accurate to within 1/100th of a mm. 100 day money back guaranteed. The SomnoDent Herbst Advance Elite is a Herbst-style appliance that is individually milled from one piece of pre-cured PMMA for greater flexural strength. All the patented strength improvements in the Herbst Advance are also found in the Herbst Advance Elite. SomnoMed will replace it for free if it breaks, no questions asked, for 3 years. The Herbst Advance Elite is only supplied with a Bflex soft inner liner for increased comfort and unsurpassed retention. Not provided.
