Who is the manufacturer of ASD Oral Appliances?

American Sleep Dentistry filed the 510(k) submission for ASD Oral Appliances (K163580).

What is the FDA product code for ASD Oral Appliances?

LRK. It is classified under 21 CFR 872.5570 as a Class 2 device in the Dental panel.

What is the regulatory pathway for ASD Oral Appliances?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ASD Oral Appliances?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ASD Oral Appliances

Q: What are the predicate devices for ASD Oral Appliances?

American Sleep Association (ASA) Oral Appliances (K130504).

K163580 · American Sleep Dentistry · LRK · Jun 8, 2017 · Dental

Device Facts

Record ID	K163580
Device Name	ASD Oral Appliances
Applicant	American Sleep Dentistry
Product Code	LRK · Dental
Decision Date	Jun 8, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5570
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.

Device Story

ASD Oral Appliances comprise five patient-specific, removable intraoral models (Anterior, Mezzo, Lateral, Elastic, Lateral Mezzo) designed to reposition the mandible forward. This mechanical action prevents soft tissue of the throat from collapsing and obstructing the airway, thereby reducing snoring and mild-to-moderate OSA. Devices are fabricated from thermoformed polymers (copolyester, EVA) and stainless steel or latex-free polymer components. A clinician fits the device to the patient's anatomy; the patient then uses the device at home during sleep. The device requires no energy source. By maintaining a forward mandibular position, the appliance helps maintain airway patency, potentially benefiting patients by alleviating sleep-disordered breathing symptoms.

Clinical Evidence

No clinical data provided; substantial equivalence is based on descriptive characteristics and technological comparison to legally marketed predicate devices.

Technological Characteristics

Intraoral mandibular repositioning device. Materials: thermoformed polymers (copolyester, EVA) and stainless steel or latex-free polymer connectors. Form factor: patient-specific upper and lower trays. Mechanism: hook and base or elastic band/strap systems. Non-sterile; cleaned by patient. No energy source. No software or algorithm.

Indications for Use

Indicated for reduction of nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.

Regulatory Classification

Identification

Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.

Special Controls

*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”

Predicate Devices

American Sleep Association (ASA) Oral Appliances (K130504)

Reference Devices

Removable Acrylic Herbst (K070327)
TAP III (K062951)
EMA (K971794)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or head in profile, with flowing lines suggesting movement or connection. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 8, 2017 American Sleep Dentistry Ryan Gregerson President 1957 West Royal Hunte Drive Ste 250 Cedar City, Utah 84720-1903 Re: K163580 Trade/Device Name: ASD Oral Appliances Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: LRK Dated: May 5, 2017 Received: May 9, 2017 Dear Ryan Gregerson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act {1}------------------------------------------------ or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Mary S. Runner -A Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K163580 Device Name American Sleep Dentistry (ASD) Oral Appliances Indications for Use (Describe) The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## K163580 510(k) Summary | Date: | May 31, 2017 | |------------------------|------------------------------------------------------------------------------------------------------------------------| | Sponsor: | American Sleep Dentistry, LLC 1957 West Royal Hunte Dr, Ste 250 Cedar City, UT 84720-1903 Phone: 800-555-1518 | | Contact Person: | Ryan Gregerson, Manager | | Trade Names: | American Sleep Dentistry (ASD) Oral Appliances | | Device Classification: | Class II | | Classification Name: | Device, Anti-Snoring and device, jaw repositioning | | Regulation: | 21 CFR 872.5570, Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea | | Device Product Code: | LRK | Device Description: The American Sleep Dentistry (ASD) Oral Appliances include five device models: the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo. All are removable, intraoral devices which reposition the mandible and each is patient specific to individual patient anatomy. The devices are comprised of thermoformed polymer splints (copolyester or EVA), which are connected via a hook and base mechanism or elastic bands or straps. Intended Use: The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate Obstructive Sleep Apnea (OSA) in individuals 18 years of age or older. ### Primary Predicate Device: American Sleep Association (ASA) Oral Appliances (K130504) ### Reference Predicate Devices: Removable Acrylic Herbst (K070327) TAP III (K062951) EMA (K971794) {4}------------------------------------------------ ### Technological Characteristics: The ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo Oral Appliances possess the same technological characteristics as one or more of the predicate devices. These include: - . Anatomic location (intraoral), - Intended Use, to treat mild to moderate sleep apnea. - Basic design (mandibular repositioning using upper and lower polymer trays with a . hook and base mechanism), - . Principles of Operation - . Materials (polymer and/or stainless steel), and - Manufacture (appliance is patient specific fabricated by prescription to the specific ● requirements of a single patient). The ASD Anterior model and predicate device, Tap III are both patient specific made Oral Appliances that include a hook and base mechanism placed on the anterior of the front teeth. The actual design differs slightly, but no new or different questions of safety and efficacy are raised by the differences. The ASD Mezzo model and predicate devices Removable Acrylic Herbst and Tap III are all patient specific made Oral Appliances that include a hook and base mechanism like the TAP III, but are placed bilaterally like that of the Herbst appliance. The actual design differs slightly, but no new or different questions of safety and efficacy are raised by the differences. The ASD Lateral model and predicate device Tap III are both patient specific made Oral Appliances that include a hook and base mechanism and is located the same as the TAP III, but the ASD Lateral model adds the additional anchors to the canine teeth for advanced stability. The actual design differs slightly, but no new or different questions of safety and efficacy are raised by the differences. The ASD Lateral Mezzo model and predicate devices Removable Acrylic Herbst and Tap III are all patient specific made Oral Appliances that include a hook and base mechanism. The ASD Lateral Mezzo hook and base mechanism is like the TAP III, but are placed bilaterally like that of the Herbst appliance. The actual design differ slightly, but no new or different questions of safety and efficacy are raised by the differences. The ASD Elastic model and predicate device EMA are both patient specific made Oral Appliances that include varying lengths of elastic bands or straps and are both placed bilaterally. The ASD Elastic, however anchors the straps in by stainless steel, while the EMA uses plastic anchors. The actual material differs slightly, but no new or different questions of safety and efficacy are raised by the differences. The fundamental scientific technology of the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo Oral Appliances is the same as previously cleared devices. {5}------------------------------------------------ | Substantial Equivalence Comparison Features | ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic and ASD Lateral Mezzo | ASA Oral Appliances [Primary Predicate] | Removable Acrylic Herbst [Reference Predicate] | Tap III [Reference Predicate] | EMA [Reference Predicate] | |-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510k # | K163580 | K130504 | K070327 | K062951 | K971794 | | Intended use/ Indications for use: | Intended for the reduction of nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older. | Intended for the reduction of nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older. | Intended for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by moving the lower jaw into a prescribed relationship to the upper jaw. | Intended to reduce or alleviate nighttime snoring and mild to moderate obstructive sleep apnea, OSA. | Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where repositioning of the mandible can increase the patient's air space | | Prescription/ OTC Use | Prescription | Prescription | Prescription | Prescription | Prescription | | Principle of Operation | Once fitted to the patient, the device positions the lower jaw forward, preventing soft tissue of the throat from collapsing and obstructing the airway, therefore alleviating or reducing the symptoms of nighttime snoring and mild to moderate | Once fitted to the patient, the device positions the lower jaw forward, preventing soft tissue of the throat from collapsing and obstructing the airway, therefore alleviating or reducing the symptoms of nighttime snoring and mild to moderate | Once fitted to the patient, the device positions the lower jaw forward, preventing soft tissue of the throat from collapsing and obstructing the airway, therefore alleviating or reducing the symptoms of nighttime snoring and mild to moderate | Once fitted to the patient, the device positions the lower jaw forward, preventing soft tissue of the throat from collapsing and obstructing the airway, therefore alleviating or reducing the symptoms of nighttime snoring and mild to moderate | Once fitted to the patient, the device positions the lower jaw forward, preventing soft tissue of the throat from collapsing and obstructing the airway, therefore alleviating or reducing the symptoms of nighttime snoring and mild to moderate | | American Sleep Dentistry, LLC ASD Oral Appliances Traditional Premarket Notification [510(k)] May 2017 | | | | | | | Substantial Equivalence Comparison Features | ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic and ASD Lateral Mezzo | ASA Oral Appliances [Primary Predicate] | Removable Acrylic Herbst [Reference Predicate] | Tap III [Reference Predicate] | EMA [Reference Predicate] | | 510k # | K163580 | K130504 | K070327 | K062951 | K971794 | | | Obstructive Sleep Apnea (OSA). | Obstructive Sleep Apnea (OSA). | Obstructive Sleep Apnea (OSA). | Obstructive Sleep Apnea (OSA). | Obstructive Sleep Apnea (OSA). | | Design: ASD Anterior | Mandibular repositioner having upper and lower polymer trays with hook and base mechanism placed on the anterior of the front teeth. | Mandibular repositioner having upper and lower polymer trays with bilateral Herbst mechanisms with bilateral, reclosable, polymer fasteners or both | Mandibular repositioner having upper and lower polymer trays with bilateral Herbst mechanisms | Mandibular repositioner having upper and lower trays with a Hook and Base mechanism placed on the anterior of the front teeth. | | | Design: ASD Mezzo | Mandibular repositioner having upper and lower polymer trays with a hook and base mechanism placed bilaterally | Mandibular repositioner having upper and lower polymer trays with bilateral Herbst mechanisms with bilateral, reclosable, polymer fasteners or both | Mandibular repositioner having upper and lower polymer trays with bilateral Herbst mechanisms | Mandibular repositioner having upper and lower trays with a Hook and Base mechanism placed on the anterior of the front teeth. | | | American Sleep Dentistry, LLC | | | Traditional Premarket Notification [510(k)] | | | | ASD Oral Appliances | | | May 2017 | | | | Substantial Equivalence Comparison Features | ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic and ASD Lateral Mezzo | ASA Oral Appliances [Primary Predicate] | Removable Acrylic Herbst [Reference Predicate] | Tap III [Reference Predicate] | EMA [Reference Predicate] | | 510k # | K163580 | K130504 | K070327 | K062951 | K971794 | | Design: ASD Lateral | Mandibular repositioner having upper and lower polymer trays with hook and base mechanism placed on the anterior of the teeth. With anchors placed on the canine teeth. | Mandibular repositioner having upper and lower polymer trays with bilateral Herbst mechanisms with bilateral, reclosable, polymer fasteners or both | Mandibular repositioner having upper and lower polymer trays with bilateral Herbst mechanisms | Mandibular repositioner having upper and lower trays with a Hook and Base mechanism placed on the anterior of the front teeth. | | | Design: ASD Lateral Mezzo | Mandibular repositioner having upper and lower polymer trays with a hook and base mechanism placed bilaterally | Mandibular repositioner having upper and lower polymer trays with bilateral Herbst mechanisms with bilateral, reclosable, polymer fasteners or both | Mandibular repositioner having upper and lower polymer trays with bilateral Herbst mechanisms | Mandibular repositioner having upper and lower trays with a Hook and Base mechanism placed on the anterior of the front teeth. | | | | | | | | | | ASD Oral Appliances May 2017 | | | | | | | Substantial Equivalence Comparison Features | ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic and ASD Lateral Mezzo | ASA Oral Appliances [Primary Predicate] | Removable Acrylic Herbst [Reference Predicate] | Tap III [Reference Predicate] | EMA [Reference Predicate] | | 510k # | K163580 | K130504 | K070327 | K062951 | K971794 | | Design: ASD Elastic | Mandibular repositioner having upper and lower polymer trays and elastic bands or straps with stainless steel anchors. | | | | Mandibular repositioner having upper and lower trays with bilateral elastic bands or straps with plastic anchors. | | Materials: ASD Anterior ASD Mezzo ASD Lateral ASD Lateral Mezzo | | | | | | | Polymer Splint | | PETG/TPU, EVA | Acrylic | Acrylic | | | Connecting Mechanism | | 303/304 Stainless Steel | 303/304 Stainless Steel | 303/304 Stainless Steel | | | Materials: ASD Elastic | | | | | | | Polymer Splint | PETG/TPU, EVA | | | | Acrylic | | Connecting Mechanism | Latex free Polymer | | | | Latex free Polymer | | eep Dentistry, LLC | | Traditional Premarket Notification [510(k)] | | | | | Opliances | | | | May 2017 | | | ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic and ASD Lateral Mezzo | ASA Oral Appliances [Primary Predicate] | Removable Acrylic Herbst [Reference Predicate] | Tap III [Reference Predicate] | EMA [Reference Predicate] | | | K163580 | K130504 | K070327 | K062951 | K971794 | | | | | | | | | | Front to back +/- 1 mm | Front to back +/- 1 mm | Front to back +/- 1 mm | Front to back +/- 1 mm | Front to back +/- 1 mm | | | Patients diagnosed with mild to moderate Obstructive | Patients diagnosed with mild to moderate Obstructive | Patients diagnosed with mild to moderate Obstructive | Patients diagnosed with mild to moderate Obstructive | Patients diagnosed with mild to moderate Obstructive | | # B. Substantial Equivalence Comparison Table: {6}------------------------------------------------ {7}------------------------------------------------ Traditional Premarket Notification [510(k)] {8}------------------------------------------------ Traditional Premarket Notification [510(k)] {9}------------------------------------------------ American Sleep ASD Oral Applia Substantial Equivalence Comparison Features 510k # | Range and precision of adjustment | Front to back +/- 1 mm | Front to back +/- 1 mm | Front to back +/- 1 mm | Front to back +/- 1 mm | Front to back +/- 1 mm | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Target Population | Patients diagnosed with mild to moderate Obstructive Sleep Apnea | Patients diagnosed with mild to moderate Obstructive Sleep Apnea | Patients diagnosed with mild to moderate Obstructive Sleep Apnea | Patients diagnosed with mild to moderate Obstructive Sleep Apnea | Patients diagnosed with mild to moderate Obstructive Sleep Apnea | | Where Used: | Fitted by a clinician, used at home. | Fitted by a clinician, used at home. | Fitted by a clinician, used at home. | Fitted by a clinician, used at home. | Fitted by a clinician, used at home. | | Energy Used/ Delivered: | None | None | None | None | None | | Human Factors: | The device is fitted by the dentist. The patient is instructed in its use and care. Subsequent use by the patient is as directed by the dentist in accordance with the provided instructions for use. | The device is fitted by the dentist. The patient is instructed in its use and care. Subsequent use by the patient is as directed by the dentist in accordance with the provided instructions for use. | The device is fitted by the dentist. The patient is instructed in its use and care. Subsequent use by the patient is as directed by the dentist in accordance with the provided instructions for use. | The device is fitted by the dentist. The patient is instructed in its use and care. Subsequent use by the patient is as directed by the dentist in accordance with the provided instructions for use. | The device is fitted by the dentist. The patient is instructed in its use and care. Subsequent use by the patient is as directed by the dentist in accordance with the provided instructions for use. | | | | | | | | {10}---------------…

ASD Oral Appliances

Device Facts

Indications for Use

Device Story

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Technological Characteristics

Indications for Use

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

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