DR. B'S MOUTHPIECE, MODEL 32129-10002

K991948 · Snore - Ezzer · LRK · Sep 2, 1999 · Dental

Device Facts

• Record ID: K991948
• Device Name: DR. B'S MOUTHPIECE, MODEL 32129-10002
• Applicant: Snore - Ezzer
• Product Code: LRK · Dental
• Decision Date: Sep 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To Alleviate or correct simple snoring by maintaining an open airway during sleep and to prevent bruxing and grinding of teeth.

Device Story

Dr. B's Mouthpiece is an oral appliance designed to alleviate simple snoring and prevent bruxism. The device functions by maintaining an open airway during sleep. It is intended for use by patients during sleep. The device is a mechanical oral appliance; it does not utilize electronic components, software, or algorithms. It is provided as a finished device for patient use to improve sleep quality by reducing snoring and protecting teeth from grinding.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical oral appliance. No electronic components, energy sources, or software. Materials and specific dimensions not detailed in the provided documentation.

Indications for Use

Indicated for individuals suffering from simple snoring and bruxism (teeth grinding) during sleep. No specific age or gender restrictions provided.

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.”

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1999

Mr. Robert A. Gall Snore-Ezzer, LLC 1217 South Grandview Boulevard Waukesha, Wisconsin 53188

Re: K991948 Dr. B's Mouthpiece, Model 32129-10002 Trade Name: Requlatory Class: Unclassified Product Code: LRK June 4, 1999 Dated: Received: June 9, 1999

Dear Mr. Gall:

We have reviewed your Section 510(k) notification of intent to we have reviewed joarenced above and we have determined the market the devicetially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate able beated in tho 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

{1}------------------------------------------------

Page 2 - Mr. Gall

the Act for devices under the Electronic Product Radiation the Act for devices under the Electronic Froductions.
Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as the FDA This letter will allow you to begin marketing for the FDA
described in your 510(k) premarket notification. The FDA described in your 510 (k) premarket notification. - Ene Flegally
finding of substantial equivalence of your device to a ror your finding of substantial equivalence of your device of a response marketed predicate device results in a crassirsdated by of
device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling
and and and 173 and 201 and additionally 809.10 for in If you desire specific advice for your additionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 CPR Part 801 and addressat the Office of
vitro diagnostic devices), please contact the Office of yitro diagnostic devices), please contact the original on and Compliance at [phone]. Additionariy, Los as Contact
the promotion and advertising of your device, please not the promotion and advertising of your device, proad be and and and the office of the Office of the Office of Compliance at (301) 334 reference to the regulation entification" (21 CFR 807.97). Other general
premarket notification" (21 CFR 807.97). Other general premarket notification" (21 CFR 807.97). Sthe Act may be information on your responsibilities ands- turers Assistance
obtained from the Division of Small Manufacturers Assistance obtained from the Division of Smart Manufacturer [phone]) or at
at its toll-free number [phone] or [phone] or at at its toll-free number [phone] of (302) 113 -0.
its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number ( if known )

Device Name:

DR. B'S Mouthpiece

Indication For Use:

To Alleviate or correct simple snoring by maintaining an open airway during sleep and to prevent bruxing and grinding of teeth.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rmoner

Division Sign-Off (Division Sign-On)
Division of Dental, Infection Control, and General Hospital Device 510(k) Number

Prescription Use OR L ( Per 21 CFR 801.109 )

Over-TheCounter Use

( Optional Format 1-2-96 )

510(k) Snore-Ezzer, LLC

22