SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE

K071404 · Power Products, Inc.-Splintek · MQC · Aug 17, 2007 · DE

Device Facts

• Record ID: K071404
• Device Name: SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE
• Applicant: Power Products, Inc.-Splintek
• Product Code: MQC · DE
• Decision Date: Aug 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Prescription Indications for Use: Protection against teeth grinding, bruxism & jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and TMJ caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle. OTC Indications for Use: The SleepRight® adjustable night guard is indicated for the protection against bruxism or night time teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Device Story

Adjustable oral appliance providing barrier between upper and lower posterior teeth; flexible connecting strap with 4 adjustments for articulating bite pads. Used by patients to prevent tooth damage and noise from bruxism/grinding. Prescription version also used for short-term relief of muscle spasms and TMJ-related tension. Device is non-boil, preformed, and reusable. Operates as a mechanical physical barrier; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Adjustable oral appliance; materials include Elvax strap, Polypropylene, Kraton, Polyurethane, and Pellethane bite pads. Mechanical design features flexible connecting strap and 4-position adjustable bite pads. No energy source, software, or connectivity. Reusable, non-sterile, non-boil, preformed design.

Indications for Use

Indicated for patients requiring protection against bruxism, nighttime teeth grinding, and jaw clenching. Prescription version indicated for short-term pain relief from muscle spasms due to occlusal interference and prevention of chronic tension and TMJ syndrome caused by chronic jaw clenching.

Predicate Devices

• EZ Splint - Power Products / Splintek
• The Doctor's® NightGuard - Dental Concepts, LLC

Submission Summary (Full Text)

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# II. 510(k) Summary

AUG 17 2007 This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.

## General Information:

| A. | Submitted By: | Splintek - Power Products Inc.<br>3325 Wyoming St<br>Kansas City, MO 64111<br>Tel: [phone]<br>Fax: [phone] |
|----|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Dr. T. J. Brown |
| | Date Prepared | July 25, 2007 |
| B. | Device Trade Name: | SleepRight® -Select, SleepRight®-Low Profile and<br>SleepRight®-Advance,<br>SleepRight® - Low Profile Rx and<br>SleepRight® - Advance Rx |
| | Common Name: | Mouthguard/nightguard |
| | Classification Name: | Unclassified |
| C. | Predicate Devices: | EZ Splint - Power Products / Splintek<br>The Doctor's® NightGuard - Dental Concepts, LLC |

#### D. Device Description:

An adjustable protector that provides a barrier between the upper and lower posterior teeth. The flexible connecting strap provides 4 adjustments for articulating bite pads.

- E. Prescription Indications for Use:
- . Protection against teeth grinding, bruxism & jaw clenching.
- Short-term pain relief from muscle spasm due to occlusal interference. .
- For the prevention of chronic tension and TMJ caused by chronic jaw clenching of . the mandibular and maxillary teeth by the temporalis muscle.

OTC Indications for Use:

The SleepRight® adjustable night guard is indicated for the protection against bruxism or night time teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

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- F. Comparison of Technical Characteristics to Predicate Device:

| Element of<br>Comparison | Subject Device<br>SleepRight® | Predicate<br>EZ Splint | Predicate<br>Doctor's<br>NightGuard |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical<br>Characteristics<br>Material<br>Select<br>Low Profile | Same<br>Same | Elvax® strap,<br>Polypropylene and<br>Kraton® bite pads | Elvax resin and<br>Elvaloy® |
| Advance | Elvax Strap<br>Polyurethane and<br>Pellethane bite pads. | | |
| Method of<br>Manufacture | Same | Injection Molded | Injection Molded |
| Rx or OTC | N/A | Rx | OTC |
| Reusable | Same | Yes, single consumer | Yes, single consumer |
| Design | Same as EZ Splint | Partial coverage,<br>preformed oral<br>appliance with<br>adjustable bite pads.<br>No boiling required. | Full coverage of<br>upper arch.<br>Uses boil and bite<br>technology to adjust<br>fit. |
| Indications for<br>Use | Protection against<br>bruxism or nighttime<br>teeth grinding. It is<br>intended to reduce<br>damage to the teeth<br>and to prevent the<br>noise associated with<br>bruxing or grinding. | Protection against<br>teeth grinding,<br>bruxism & jaw<br>clenching.<br><br>Short-term pain<br>relief from muscle<br>spasm due to<br>occlusal interference.<br><br>For the prevention of<br>chronic tension and<br>TMJ caused by<br>chronic jaw<br>clenching of the<br>mandibular and<br>maxillary teeth by<br>the temporalis<br>muscle. | Protection against<br>bruxism or nighttime<br>teeth grinding. It is<br>intended to reduce<br>damage to the teeth<br>and to prevent the<br>noise associated with<br>bruxing or grinding. |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's stylized logo, which consists of three abstract human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 7 2007

Splintek - Power Products C/O Ms. Melanie K. Hasek, RAC Senior Project Manager, Regulatory Affairs PRA International 9755 Ridge Drive Lenexa, Kansas 66219

Re: K071404

Trade/Device Name: SleepRight® - Select SleepRight® - Low Profile and SleepRight® - Advance SleepRight® - Low Profile Rx and SleepRight® - Advance Rx Regulation Number: Unclassified Regulation Name: Not Applicable Regulatory Class: Unclassified Product Code: MQC and OBR Dated: July 25, 2007 Received: July 27, 2007

Dear Ms. Hasek:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Hasek

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Mibranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D.

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

#### Enclosure

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## Indications for Use Form

Page 1 of 1

510(k) Number (if known): K071404

Device Name: SleepRight® - Low Profile Rx and SleepRight® - Advance Rx

Indications For Use (Rx):

- Protection against teeth grinding, bruxism and jaw clenching .
- Short-term pain relief from muscle spasm due to occlusal interference. .
- For the prevention of chronic tension and temporomandibular joint (TMJ) . syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Super Runne

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K071404

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## I. Indications for Use:

## Indications for Use Form

Page 1 of 1

510(k) Number (if known): ★071404

Device Name: SleepRight® - Select, SleepRight® - Low Profile and SleepRight® - Advance

Indications For Use (OTC):

The SleepRight® adjustable night guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

*Over-The-Counter Use* X
(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Runco

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: KC71404