Who is the manufacturer of FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR?

Bryan Keropian Dds filed the 510(k) submission for FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR (K061228).

What is the FDA product code for FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR?

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

What is the regulatory pathway for FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR?

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

What are the predicate devices for FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR?

Quiet Night & Quiet Night MA (K032410); Full Breath Sleep Appliance Anterior Bite With and Without Bumps (K052862); Full Breath Sleep Appliance Posterior Bite With and Without Bumps (K053065).

Who can help prepare an FDA 510(k) submission like FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR?

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.

FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR

K061228 · Bryan Keropian Dds · LQZ · May 26, 2006 · Dental

Device Facts

Record ID	K061228
Device Name	FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
Applicant	Bryan Keropian Dds
Product Code	LQZ · Dental
Decision Date	May 26, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5570
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Full Breath Sleep Appliance With Posterior Tongue Depressor- This appliance is indicated for the treatment of snoring. Full Breath Sleep Appliance With Posterior Tongue Depressor This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.

Device Story

Full Breath Sleep Appliance is a custom-fitted intraoral device; features anterior bite and posterior tongue depressor/restrainer. Designed for use by patients under physician supervision; prescribed for snoring and mild-to-moderate obstructive sleep apnea (OSA). Device functions by repositioning the jaw and restraining the tongue to maintain airway patency during sleep. Patient wears appliance intraorally at night; mechanical design prevents tongue collapse and promotes airway opening. Benefits include reduction in snoring frequency/intensity and mitigation of OSA symptoms. No electronic components or software.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, intended use, and technological characteristics compared to predicate devices.

Technological Characteristics

Intraoral jaw repositioning device; features anterior bite and posterior tongue depressor. Mechanical design; non-powered; non-electronic. Custom-fitted to patient anatomy. No software or algorithm.

Indications for Use

Indicated for treatment of snoring and mild to moderate obstructive sleep apnea in adults. Prescription use only.

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

Quiet Night & Quiet Night MA (K032410)
Full Breath Sleep Appliance Anterior Bite With and Without Bumps (K052862)
Full Breath Sleep Appliance Posterior Bite With and Without Bumps (K053065)

Reference Devices

Breathe EZ Anti-Snoring Device (K022891)
SleepBite (K103808)
Dr. B's Mouthpiece (K991948)
NTI Tension Suppression System (K010876)

Related Devices

K091035 — FULL BREATH SLEEP APPLIANCE LOWER (FBSL) · Bryan Keropian Dds · Jun 24, 2009
K100185 — SLEEP APP · Sleep Medicine Network, Inc. · Nov 19, 2010
K052862 — FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) · Bryan Keropian Dds · Dec 30, 2005
K202529 — ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring · Prosomnus Sleep Technologies, Inc. · Nov 20, 2020
K974531 — SNORE-EZZER · Snore - Ezzer · Feb 12, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ K061228 MAY 2 6 2006 510(k) Summary Full Breath Sleep Appliance Anterior Bite With Posterior Tongue Depressor Full Breath Sleep Appliance Posterior Bite With Posterior Tongue Depressor Applicant Bryan Keropian DDS 18607 Ventura Blvd., Suite 206 Tarzana, CA 91356 Product Name Full Breath Sleep Appliance Anterior Bite With Posterior Tongue Depressor Full Breath Sleep Appliance Posterior Bite With Posterior Tongue Depressor Proposed Product Code LQZ Proposed Device Classification Jaw Repositioning Device Contact Person Bryan Keropian DDS tmjrelief(@msn.com Telephone W - 818-881-7233 H-818-716-0579 C - 818-251-0541 ## Fax 818-881-7541 510(k) Application Preparation Bryan Keropian, DDS {1}------------------------------------------------ K06/228 20fz ## 510(K) Summary (continued) For the treatment of mild and moderate OSA, the Full Breath Sleep Appliance With Posterior Tongue Restrainer is substantially equivalent (SE) to the Quiet Night & Quiet Night MA (K032410), The Full Breath Sleep Appliance Anterior Bite With and Without Bumps (K052862), and the Full Breath Sleep Appliance Posterior Bite With and Without Bumps (K053065) For the treatment of snoring, the Full Breath Appliance With Posterior Tongue Restrainer is SE to the Quiet Night & Quiet Night MA (K032410), The Full Breath Sleep Appliance Anterior Bite With and Without Bumps (K052862), and the Full Breath Sleep Appliance Posterior Bite With and Without Bumps (K053065), the Breathe EZ Anti-Snoring Device (K022891), the SleepBite (K103808), and Dr. B's Mouthpiece (K991948). | For the treatment of bruxism, the Full Breath Sleep Appliance is SE to the NTI Tension | | |------------------------------------------------------------------------------------------|--| | Supression System (K010876), the Breathe EZ Anti-Snoring device (K022891), the SleepBite | | | (K103808). And Dr. B's Mouthpiece (K991948). | | | Product Name | Full Breath Sleep Appl. FBAB&FBPB | Quiet Night Quiet Nt. MA | NTI Tension Suppression System | Breathe EZ Anti-Snoring Device | Sleepbite | Dr. B's Mouthpiece | |-----------------------|------------------------------------------|------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------|-------------------------------|-------------------------------| | 510(k) | K052862 K053065 | K032410 | K010876 | K022891 | K103808 | K991948 | | Product Code | LOZ | LOZ | LOZ | LRK | LRK | LRK | | Indicated Use | Treatment of Mild & Mod. OSA -- | Treatment of Mild & Mod. OSA -- | Prophylactic treatment of medically diagnosed migraine pain -- | | | | | | Treatment of Snoring -- | Treatment of Snoring -- | | Treatment of snoring -- | Treatment of snoring -- | Treatment of snoring -- | | | Prevent Bruxism | Prevent Bruxism | Prevent Bruxism | Prevent Bruxism | Prevent Bruxism | Prevent Bruxism | | | | | | | | | | Method of Delivery | By prescription | By prescription | By prescription | By prescription | By prescription | By prescription | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The overall design is simple and recognizable, representing the department's focus on health and human welfare. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 6 2006 Dr. Bryan Keropian Bryan Keropian, DDS 18607 Ventura Boulevard, Suite 206 Tarzana, California 91356 Re: K061228 Trade/Device Name: Full Breath Sleep Appliance with Posterior Tongue Depressor Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: LQZ Product Code: II Dated: May 2, 2006 Received: May 2, 2006 Dear Dr. Keropian: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {3}------------------------------------------------ ## Page 2 -Dr. Keropian 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely wours, Susan Runox Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K061228 ## Indications for Use 510(k) Number (if known): Device Name: Full Breath Sleep Appliance With Posterior Tongue Depressor Indications For Use: - 1. Full Breath Sleep Appliance With Posterior Tongue Depressor- This appliance is indicated for the treatment of snoring. - 2. Full Breath Sleep Appliance With Posterior Tongue Depressor This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea. X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan (vision Sign-C Envision of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(%) Number ..