FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)

K053065 · Bryan Keropian Dds · LQZ · Jan 3, 2006 · Dental

Device Facts

• Record ID: K053065
• Device Name: FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)
• Applicant: Bryan Keropian Dds
• Product Code: LQZ · Dental
• Decision Date: Jan 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. An oral appliance to be used for the treatment of mild and moderate Obstructive Sleep Apnea. 2. For the treatment of snoring. 3. For the prevention of bruxism.

Device Story

Custom-fabricated oral appliance; delivered by dentist. Controls vertical dimension and mandibular advancement to reduce/eliminate snoring and treat mild/moderate OSA. Features posterior trans-palatal bar to prevent tongue sealing against palate and restrain tongue from up/back movement. Used by patients during sleep. Clinical benefit includes reduced AHI/RDI and improved O2 nadir saturation.

Clinical Evidence

No clinical data provided; substantial equivalence based on design comparison to predicate.

Technological Characteristics

Custom-fabricated intraoral jaw repositioning device. Features include posterior trans-palatal bar and tongue restraint. Mechanical design; no electronic components or software.

Indications for Use

Indicated for patients with mild to moderate Obstructive Sleep Apnea, snoring, and for the prevention of bruxism.

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)

Reference Devices

• Breathe EZ Anti-Snoring Device (K022891)
• Sleepbite (K103808)
• The Silencer (K954530)

Submission Summary (Full Text)

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K053065

#### JAN 3 2006

### 510(k) Summary Full Breath Sleep Appliance - PB (Posterior Bite) Full Breath Sleep Appliance - PBB (Posterior Bite with Bumps)

Applicant

Bryan Keropian DDS 18607 Ventura Blvd., Suite 206 Tarzana, CA 91356

Product Name

Full Breath Sleep Appliance -- PB (Posterior Bite) Full Breath Sleep Appliance - PBB (Posterior Bite with Bumps)

Proposed Product Code LQZ

Proposed Device Classification Jaw Repositioning Device

Contact Person Bryan Keropian DDS tm|relief|d`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

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#### 510(K) Summary (continued)

This is a simple enhancement to the design of the Quiet Night & Quiet Night MA (K032410). It incorporates the Quiet Night function of control of vertical dimension and mandibular advancement for reduction/elimination of snoring. It also incorporates the posterior trans-palatal bar of the Quiet Night and Quiet Night MA to prevent the tongue from sealing against the palate and thus reduce snoring. It also restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping.

### DEVICE SPECIFICATIONS

The Full Breath Sleep Appliance PB & PBB is a custom device fabricated typically by a Professional dental laboratory and delivered by a dentist.

| Product<br>Name | Full Breath<br>Sleep Appl. | Quiet Night<br>Quiet Nt. MA | Breathe EZ<br>Anti-Snoring<br>Device | Sleepbite | The<br>Silencer |
|------------------|------------------------------------|-----------------------------------|--------------------------------------|-------------------------|-----------------------------------|
| 510(k) | Pending | K032410 | K022891 | K103808 | K954530 |
| Product<br>Code | LQZ | LQZ | LRK | LRK | LRK |
| Indicated<br>Use | Treatment of<br>Mild & Mod.<br>OSA | Treatment of<br>Mild & Mod<br>OSA | Treatment of<br>Snoring | Treatment of<br>Snoring | Treatment of<br>Mild & Mod<br>OSA |
| | -- | -- | | | -- |
| | Treatment of<br>Snoring | Treatment of<br>Snoring | | | Treatment of<br>Snoring |

#### Method of Delivery -By prescription By prescription By prescription By prescription By prescription

## INDICATIONS FOR USE

- I. An oral appliance to be used for the treatment of mild and moderate Obstructive Sleep Apnea.
- 2. For the treatment of snoring.
- 3. For the prevention of bruxism.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 JAN 3

Dr. Brvan Keropian 18607 Ventura Boulevard, Suite 206 Tarzana, California 91356

Re: K053065

Trade/Device Name: Full Breath Sleep Appliance – PB (Posterior Bitc) Full Breath Sleep Appliance – PBB (Posterior Bite with Bump) Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LQZ Dated: October 31, 2005 Received: November 1, 2005

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.

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#### 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 vour 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilitics under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.litml.

Sincerely yours,

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

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K053065

U.S. Food and Drug Administration FDA

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Center for Devices and Radiological Health FDA Home Page | CDRH Họme Page | Search | CDRH A-Z | ndex | Contact CDRH

# Indications for Use

510(k) Number (if known): K 05:3 Occd 3 C

Device Name: Full Breath Sleep AppliAnce - PB CPasterior Bric. Full BREAth Steep Appliance - PBB (Pasterior Bitc with Bumps , Indications for Use: ns for Use:
I) AN oral Appliance to be used For the tree the champ a moderate Obstructive Steep Aprea mild And J . F CHORING

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Prescription Use
(Part 21 CFR 801 Subpart D) X

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| http://www.fda.gov/cdrh/ode/INDICATE.HTML |
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| K053065 | 12/10/2005 |
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