SNOREFREE

K955336 · Scott Feldman Dds & Norman Shapiro Dds · LRK · Jan 4, 1996 · Dental

Device Facts

• Record ID: K955336
• Device Name: SNOREFREE
• Applicant: Scott Feldman Dds & Norman Shapiro Dds
• Product Code: LRK · Dental
• Decision Date: Jan 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

Snorefree is an oral appliance designed to reduce snoring. The device is used by patients to maintain airway patency during sleep. It functions as a mechanical dental appliance; no electronic or software components are involved. The device is intended for use in a home setting by the patient.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Mechanical oral appliance. No electronic, software, or energy-based components. Materials and specifications not detailed in the provided document.

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)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JAN - 4 1996

Scott E. Feldman, D.D.S.
Scott Feldman D.D.S. & Norman Shapiro D.D.S.
6319 Desota Avenue, Suite 401
Woodland Hills, California 91367

Re: K955336
Trade Name: Snorefree
Regulatory Class: Unclassified
Product Code: LRK
Dated: November 2, 1995
Received: November 20, 1995

Dear Dr. Feldman:

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 to 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 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 (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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Page 2 - Dr. Feldman

This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. 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), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-300) at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone].

Sincerely yours,

Timothy A. Ulatowski
Acting Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

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