SILENTNITE

K972424 · Glidewell Laboratories · LRK · Sep 18, 1997 · Dental

Device Facts

• Record ID: K972424
• Device Name: SILENTNITE
• Applicant: Glidewell Laboratories
• Product Code: LRK · Dental
• Decision Date: Sep 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the SilentNite™ device is for snore prevention.

Device Story

SilentNite™ is a mandibular repositioning (MRP) device consisting of upper and lower frames connected together. The device is custom-fitted to the patient's teeth by a dentist. It is worn at night during sleep to prevent snoring. The device functions by repositioning the mandible. It is intended for use by adults; patients suspected of having serious sleep disorders or sleep apnea must be referred to a physician for laboratory testing and diagnosis before use. The device serves as a treatment option for snoring and mild sleep apnea.

Clinical Evidence

No clinical data provided. Effectiveness is based on the wide, general use of similar predicate devices.

Technological Characteristics

The device consists of upper and lower frames attached with connectors. It is a custom-fitted oral appliance designed for nighttime wear. No specific materials, energy sources, or software components are described.

Indications for Use

Indicated for adults wishing to prevent snoring. Available by prescription from a dentist. Appropriate for mild sleep apnea when other treatments are ineffective or undesired. Contraindicated if patient has mandibular joint disease or injury, or if obstructive sleep apnea is suspected without prior evaluation by a sleep disorder specialist.

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

• SILENCER (Silent Knights Ventures, Inc.)
• THERASNORE (Dr. Thomas E. Meade)
• PM POSITIONER (Dental Services Group)
• KLEARWAY (Great Lakes Orthodontics)
• SNOREFREE (Space Maintainers Laboratory)
• SNORNOMORE (Annalan Labs)
• "Z" ("Z" Training)

Submission Summary (Full Text)

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# (977474

510(k) Premarket Notification Submission SilentNite™ Snore Prevention Device

# 501(k) Summarv

#### Submitter:

SEP 1 8 1997

Glidewell Laboratories 4141 MacArthur Blvd. Newport Beach, CA 92660 Contact Person: Keith D. Allred Telephone: [phone] Telefax: [phone]

# Date Summary was prepared: June 25, 1997

#### Device Name:

- · Trade Name SilentNiteTM
- · Common Name Snoring Device
- · Classification Unclassified
- · Product Code LRK

Description: The SilentNite™ device is comprised of upper and lower frames that are attached with connectors. The frames are form fitted to the teeth and are meant to be worn at night while sleeping.

Intended Use: The intended use of the SilentNite™ device is for snore prevention.

# Substantial Equivalence:

The SilentNite™ device is substantially equivalent to several other legally marketed devices in the United States. Substantially equivalent devices include the following: SILENCER by Silent Knights Ventures, Inc., THERASNORE by Dr. Thomas E. Meade, PM POSITIONER by Dental Services Group, KLEARWAY by Great Lakes Orthodontics, SNOREFREE by Space Maintainers Laboratory, SNORNOMORE by Annalan Labs, and "Z" by "Z" Training.

# Safety and Efficacy:

The SilentNite™ device functions in a similar manner to other comparative predicate devices and the intended use is the same. The differences between the device and predicate devices are minor and do not raise new safety concerns. The effectiveness and suitability to the intended purpose of the product is assured through the wide, general use of similar other predicate devices and demonstrates the safe use of the device in many practitioner's hands.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Keith D. Allred Glidewell Laboratories 4141 Macarthur Boulevard 92660 Newport Beach, California

Re: K972424 Silentnite Trade Name: Regulatory Class: Unclassified Product Code: LRK Dated: June 25, 1997 Received: June 27, 1997

SEP 1 8 1997

Dear Mr. Allred:

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 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 Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531

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Page 2 - Mr. Allred

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricici Curentiffor

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

Enclosure

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510(k) Number (if known):

SILENT NITE

K972424

Device Name:

Indications For Use:

The SilentNite™ mandibular repositioning (MRP) device is indicated for persons who wish to prevent snoring and is available only from a dentist by prescription. It has been estimated that 6 million or more adults (with men outnumbering women 8 to 1) snores, and that 10% may have sleep apnea. If an examination of the patient, together with the patient's responses to a questionnaire, indicate the possibility of a more serious sleep disorder than "primary" or "social" snoring, the patient should be referred to a physician who can diagnose sleep apnea based on testing in a sleep laboratory and suggest treatment options. Necessary treatment for serious cases of sleep apnea may include surgery, or a medically prescribed treatment called nasal continuous positive airway pressure, or a MRP device. MRP devices may be appropriate treatment for persons with mild sleep apnea when surgical and other medical treatments are ineffective or not desired. Contraindications for use: Based on the dentists examination and the patient's responses the questionnaire, obstructive sleep apnea may either be indicated or cannot be excluded. In such event, an examination by a sleep disorder specialist is recommended before prescribing the SilentNite™ snoring device. If the dentist's examination and the patient's responses to the questionnaire indicate the possibility of disease or injury to the mandibular joint, the SilentNite™ snoring device is contraindicated and should not be prescribed, to avoid the possibility of further damage to the mandibular joint.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Heald Shirmer
(Division Sign or)

Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972471

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use