SLEEPRIGHT

K100545 · Power Products, Inc.-Splintek · OBR · Jun 4, 2010 · DE

Device Facts

• Record ID: K100545
• Device Name: SLEEPRIGHT
• Applicant: Power Products, Inc.-Splintek
• Product Code: OBR · DE
• Decision Date: Jun 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The SleepRight® Original 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

SleepRight Original is an adjustable oral appliance for home use by adults to manage bruxism. Device consists of flexible Elvax strap connecting two polypropylene bite pads; provides barrier between upper and lower posterior teeth. User adjusts strap to fit bite pads; device worn at night. Acts as physical buffer to prevent tooth-to-tooth contact, reducing dental damage and grinding noise. Reusable, non-sterile, OTC device. Patient monitors for adverse reactions or changes in bite; consults dentist every 6 months.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on descriptive comparisons of design, materials, and intended use.

Technological Characteristics

Materials: Elvax strap, polypropylene bite pads. Design: Adjustable oral appliance with 5-position flexible strap. Energy source: None (mechanical). Connectivity: None. Sterilization: Non-sterile. Software: None.

Indications for Use

Indicated for individuals over 18 years of age for protection against bruxism or nighttime teeth grinding to reduce tooth damage and noise. Contraindicated for individuals with TMJ, loose fillings, loose caps, unfilled cavities, jaw clicking/pain, face pain, difficulty chewing, mouth sores, gum disease, bleeding gums, or serious respiratory problems. Not for use with dentures, braces, or other dental appliances.

Regulatory Classification

Identification

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Predicate Devices

• SleepRight -Low profile (K071404)

Submission Summary (Full Text)

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K100545

## II. 510(k) Summary

JUN - 4 2010

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

Dr. T. J. Brown

## General Information:

| A. Submitted By: | Splintek, Inc.<br>3325 Wyoming St<br>Kansas City, MO 64111<br>Tel: [phone]<br>Fax: [phone] |
|------------------|------------------------------------------------------------------------------------------------------|
|------------------|------------------------------------------------------------------------------------------------------|

Contact Person:

May 27, 2010 Date Prepared

- SleepRight® Original B. Device Trade Name:
Mouthguard Common Name:

Unclassified Classification Name:

SleepRight® -Low profile Predicate Devices: C.

Device Description: D.

> An adjustable protector that provides a barrier between the upper and lower posterior teeth. The flexible connecting strap provides 5 adjustments for the bite pads.

#### OTC Indications for Use: E.

The SleepRight® Original 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.

Cautions: Do not use if you are under 18 years of age; have TMJ; have teeth or jaw caint or if the dental guard is broken or damaged. Do not use as an athletic mouth pains, or it als tuse for more than 12 hours in a 24 hour period. Not for use with dentures, braces or other dental appliances. Do not use for more than 3 months dentifely bruces or built consulting your dentist. Ask a dentist before use if you have loose fillings, loose caps, or unfilled cavities; jaw clicking or pain, teeth pain, face pain; difficulty chewing; mouth sores; gum disease or bleeding gums; or serious respiratory problems. While using the product, see your dentist at least

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K100545

20

every 6 months. Stop use and see a dentist if you develop loose teeth or a change in every o months. "We're ain or other irregularity; the product easily falls out of your your bit, experience pain or other welg bleeding gums, soreness, or other reaction inside your mouth.

| Element of Comparison | Subject Device<br>SleepRight® Original | Predicate<br>SleepRight® -Low profile |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K100545 | K071404 |
| Device Description: | An adjustable protector that<br>provides a barrier between<br>the upper and lower<br>posterior teeth. The<br>flexible connecting strap<br>provides 5 adjustments for<br>the bite pads. | An adjustable protector that<br>provides a barrier between the<br>upper and lower posterior<br>teeth. The flexible connecting<br>strap provides 4 adjustments<br>for articulating bite pads. |
| Physical Characteristics<br>Material | Elvax® strap,<br>Polypropylene bite pads | Elvax® strap, Polypropylene<br>and Kraton® bite pads |
| Thermal Safety | Same | Warm water (not boiling) is<br>recommended for fitting. |
| Method of Manufacture | Same | Injection Molded |
| Rx or OTC | OTC | Rx and OTC |
| Reusable | Same | Yes, single patient |
| Sterile | Same | No |
| Method of Disinfection | Same | Cool water, mouthwash or<br>toothpaste. |
| Design | Same except bite pads do<br>not articulate | Partial coverage, preformed<br>oral appliance with adjustable<br>bite pads. No boiling<br>required. |
| Compatibility with<br>Environment & Other<br>Devices | Same | Biocompatible materials used. |
| Indications for Use | Same | Protection against bruxism or<br>nighttime teeth grinding. It is<br>intended to reduce damage to<br>the teeth and to prevent the<br>noise associated with bruxing<br>or grinding. |
| OTC | Same | |
| Target Population | Same | Individuals over the age of 18<br>who clench and grind their<br>teeth. |
| Where used | Same | For home use. |
| Flavored | No | Yes |

- Comparison of Technical Characteristics to Predicate Device: F.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an eagle-like emblem with three stylized shapes representing the human form. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

# JUN - 4 2010

Power-Products-Incorporated-Splintek · C/O Ms. Melaine Hasek Senior Regulatory Affairs Manager PRA International 9755 Ridge Drive Lenexa, Kansas 66219

Re: K100545

Trade/Device Name: SleepRight® Original Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: May 28, 2010 Received: June 1, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Melanie 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K100545

# I. Indications for Use:

Indications for Use Form

510(k) Number (if known):

Device Name: SleepRight Original

Indications For Use [Over The Counter (OTC)]:

The SleepRight Original 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
(21 CFR 801 Subpart C) X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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510(k) Number: K100545

Splintek, Inc.

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