SNOREX

K971818 · Snorex (Nz) , Ltd. · LQZ · Dec 18, 1997 · Dental

Device Facts

• Record ID: K971818
• Device Name: SNOREX
• Applicant: Snorex (Nz) , Ltd.
• Product Code: LQZ · Dental
• Decision Date: Dec 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To maintain open airways and thereby reduce or eliminate snoring and sleep apnea.

Device Story

SNOREX is a custom-formed mandibular splint; functions by holding the lower jaw in a forward position during sleep to maintain open airways; intended to reduce or eliminate snoring and sleep apnea. Device is worn by the patient during sleep. Clinical benefit derived from mechanical airway maintenance. No hinge mechanism used; mandibular advancement and alignment achieved through custom manufacturing procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Custom-formed mandibular splint; non-hinged design; relies on mechanical positioning of the mandible to maintain airway patency.

Indications for Use

Indicated for individuals who snore and desire to alleviate or eliminate snoring, provided they possess sufficient natural upper and lower teeth to retain the appliance during sleep.

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

• THE SILENCER APPLIANCE

Submission Summary (Full Text)

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K971818

# 510(k) SUMMARY DEC 18 1997

Submitted by:

Vernon Pribble 8210 Carrleigh Parkway Springfield, VA 22152

Phone/Fax [phone]

Contact Person:

:

Vernon Pribble (see above)

Prepared:

6 May 1997

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Trade Name:

### SNOREX

Common Name:

AntiSnoring Device

Classification Name:

AntiSnoring Device

Predicate Device

The SNOREX is claiming significant equivilence to

## THE SILENCER APPLIANCE

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## Photo and Description of SNOREX

The SNOREX is a custom formed mandibular splint designed to hold the lower jaw in a forward position while sleeping.

Image /page/2/Picture/2 description: The image shows two bone fragments against a black background. The bone fragments appear to be parts of a jawbone, with visible teeth sockets. The fragments are illuminated, making them stand out against the dark background. The image is in black and white.

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Intended Use of the Device

To maintain open airways and thereby reduce or eliminate snoring and sleep apnea.

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## Summary of Technological Characteristics of SNOREX

Compared To

#### The Silencer Appliance

The SNOREX and the SILENCER are comparable in all aspects with the exception of the "Halstrom Hinge". The amount of advancement of the mandible and precision alignment is achieved by the SNOREX manufacturing procedure without the use of a hinge.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Vernon Pribble Owner/Operator Snorex (NZ) Ltd. 12 Kura Place, Torbay North Shore City, New Zealand

DEC 18 1997

K971818 Re : Trade Name: Snorex Requlatory Class: Unclassified Product Code: LQZ Dated: October 4, 1997 Received: October 10, 1997

Dear Mr. Pribble:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Druq 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

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Page 2 - Mr. Pribble

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 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.ffla.gov/cdrh/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

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510(k) Number (if known):

SNOREX Device Name:

#### Indications for Use:

The use of the SNOREX device is indicated for anyone who snores, has a desire to alleviate or eliminate snoring, and has sufficient natural upper and lower teeth to hold the appliance in place while sleeping.

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

Concurrence of DCRHL, Office of Device Evaluation (ODE)

| | Swner Runner |
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| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K971818 |

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
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