SNORE-CURE ANTI-SNORING APPLIANCE

{0}------------------------------------------------ K980952 JUN 1 1998 # 510(k) Summary for SNORE-CURE Anti-snoring Appliance ### DATE PREPARED 1. March 4, 1998 ## SPONSOR INFORMATION 2. # Main Office Dr. Earl Bergersen c/o: Ortho-Tain, Inc. Carr. 861, Km. 5.0 Toa Alta, Puerto Rico 00953 Mailing address Box 4296 Bayamon Gardens Station Bayamon, Puerto Rico 00958 Contact Person: Dr. Earl O. Bergersen (800) 468-0737 (telephone) (787) 780-5330 (787) 799-5074 (facsimile) Qutside Regulatory Counsel McDermott, Will & Emery 600 13th Street, N.W. Washington, D.C. 20005-3096 (202) 756-8075 (telephone) (202) 756-8087 (facsimile) 1. ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Contact Person: David L. Rosen, R.Ph., J.D. {1}------------------------------------------------ #### DEVICE NAME 3. SNORE-CURE Anti-snoring Appliance Proprietary Name: Common/Usual Name: Anti-snoring Appliance Classification Name: Unclassified ## DEVICE DESCRIPTION AND INTENDED USE 4. The SNORE-CURE Anti-snoring Appliance is intended as an aid in the The SNORE-COND And-anoring rippinh. Iower jaw slightly forward and open alleviation of shoring of repearand the patient's airway, thereby decreasing air turbulence. #### PREDICATE DEVICE 5. The SNORE-CURE Anti-snoring Appliance is substantially equivalent to the Snore-Guard device by Distar Incorporated cleared by FDA on on April 14, 1989 under 510(k) K882303/C in design, materials, and intended use. #### DEVICE TESTING 6. The SNORE-CURE Anti-snoring appliance is preformed and is substantially similar in design, materials and function to the Snore-Guard product by Distar Incorporated cleared by FDA on April 14, 1989 under 510(k) K882303/C. The SNORE-CURE, like the predicate device, the Snore-Guard, advances the mandible anteriorly and open the mandible vertically. The SNORE-CURE appliance advances the mandible 6-7mm anteriorly with an average overjet of 4mm and opens the mandible 8mm. The Snore-Guard advances the mandible about 6-8mm anteriorly, and opens the mandible 7-8mm. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 1 1008 JUN Ortho-Tain, Incorporated C/O David L. Rosen, R.Ph., J.D. ttorney at Law McDermott, Will & Emery 600 13th Street N.W. Washington, DC 20005-3096 K980952 Re : SNORE-CURE® Anti-Snoring Appliance Trade Name: Unclassified Regulatory Class : LRK Product Code: March 12, 1998 Dated: March 13, 1998 Received: Dear Mr. Rosen: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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.). You may, therefore, market the device, subject to the general The general controls - controls provisions of the Act. provisions of the Act include requirements for annual provisions of the ing 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 be addice to back and your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਦੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory -------In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 {3}------------------------------------------------ Page 2 - Mr. Rosen through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification™ (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # ÖRIGINAL 510(k) Number (if known): Not assigned yet Device Name: Trade Name: SNORE-CURE® Anti-snoring Appliance Indications for Use: The SNORE-CURE Anti-snoring Appliance is intended as an aid in the alleviation of snoring by repositioning the lower jaw slightly forward and open together with the tongue to expand the patient's airway, thereby decreasing air turbulence. > PLEASE DO NOT WRITE BELOW THIS LINE (Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Seusa Rurels (Division Six = 11) ivision of Demai. Infection Control, and General Hospital Devices **510(k) Number** 16980952 **Prescription Use** (Per 21 CFR 801.109) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Or