FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)

K052862 · Bryan Keropian Dds · LQZ · Dec 30, 2005 · Dental

Device Facts

• Record ID: K052862
• Device Name: FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)
• Applicant: Bryan Keropian Dds
• Product Code: LQZ · Dental
• Decision Date: Dec 30, 2005
• 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; used for mild/moderate Obstructive Sleep Apnea (OSA), snoring, and bruxism. Design incorporates anterior discluding element for bruxism control and vertical dimension management; anterior mandibular advancement for snoring reduction; posterior trans-palatal bar to prevent tongue-palate seal and restrain posterior tongue movement. Device functions by repositioning jaw and restraining tongue to maintain airway patency. Clinical benefit includes reduced AHI/RDI and ODI scores. Used in clinical/home settings; patient-worn.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design comparison and intended use.

Technological Characteristics

Custom-fabricated intraoral jaw repositioning device. Features include anterior discluding element, anterior mandibular advancement mechanism, and posterior trans-palatal bar. Mechanical operation; no energy source or software.

Indications for Use

Indicated for patients with mild to moderate Obstructive Sleep Apnea, snoring, and 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)
• NTI Tension Suppression System (K010876)

Reference Devices

• Breathe EZ Anti-Snoring Device (K022891)
• Sleepbite (K103808)
• Dr. B's Mouthpiece (K991948)

Submission Summary (Full Text)

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510(k) Summary Full Breath Sleep Appliance - AB (Anterior Bite) Full Breath Sleep Appliance - ABB (Anterior Bite with Bumps)

Applicant

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

### Product Name

Full Breath Sleep Appliance - AB (Anterior Bite) Full Breath Sleep Appliance - ABB (Anterior Bite with Bumps)

Proposed Product Code LOZ

Proposed Device Classification Jaw Repositioning Device

# Contact Person

Bryan Keropian DDS [e-mail]

#### 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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K052862

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 and the NTI (K010867) anterior discluding element for bruxism and control of vertical dimension and anterior mandibular advancerient for reduction/elimination of snoring. It also has the posterior trans-palatal bar to prevent the tongue from sealing against the palate and reducing snoring, and restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's and reduction of ODI's.

# DEVICE SPECIFICATIONS

The Full Breath Sleep Appliance is a custom fabricated device 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 | NTI Tension<br>Suppression<br>System | Breathe EZ<br>Anti-Snoring<br>Device | Sleepbite | Dr. B's<br>Mouthpiece |
|-----------------------|------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------|-------------------------|-------------------------|
| 510(k) | Pending | K032410 | K010876 | K022891 | K103808 | K991948 |
| Product<br>Code | LQZ | LQZ | LQZ | LRK | LRK | LRK |
| Indicated<br>Use | Treatment of<br>Mild & Mod.<br>OSA | Prophylactic<br>treatment of<br>medically<br>diagnosed<br>migraine pain | Prophylactic<br>treatment of<br>medically<br>diagnosed<br>migraine pain | Treatment of<br>snoring | Treatment of<br>snoring | Treatment of<br>snoring |
| | -- | -- | -- | -- | -- | -- |
| | Prevent<br>Bruxism | Prevent<br>Bruxism | Prevent<br>Bruxism | Prevent<br>Bruxism | Prevent<br>Bruxism | Prevent<br>Bruxism |
| Method of<br>Delivery | By prescription | By prescription | By prescription | By prescription | By prescription | By prescription |

# PREDICATE DEVICE COMPARISON TABLE:

## INDICATIONS FOR 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.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 2005

Dr. Bryan Keropian Bryan Keropian DDS A Professional Corporation 18607 Ventura Boulevard, Suite 206 Tarzana, California 91356

Re: K052862

Trade/Device Name: Full Breath Sleep Appliance-ABCAnterior Bite) Full Breath Sleep Appliance-ABB (Anterior Bite with Bumps) Regulation Number: 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 11, 2005 Received: October 11, 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 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 [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 responsibilities 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.html.

Sincerely yours,

Shiela R. Murphy, D.O. for C. fan, M.D. 12/30/

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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K052862

U.S. Food and Drug Administration

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

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# Indications for Use

510(k) Number (if known): K 052862

Device Name: Full BREAth Sleep AppliAnce - AB(ANterion Bire) Full Breath Steep AppliAnce - ABBC Anterior Bit with Bumps Indications for Use:

1) AN ORA/ Appliance to be used for the theatment of
mild And Moderate Obstructive Sleep ApNCA
2) For the treatment of SNORING
3) For the prevENTION OF DRUKIEM.

Angela Blackwell for MSK

on Tology, Ganeral Houpil Control, Danial Davices

K052862

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

http://www.fda.gov/cdrh/ode/INDICATE.HTML

12/10/2005