DENTAL PROTECTOR

K024261 · Dental Concepts, LLC · MQC · Mar 26, 2003 · DE

Device Facts

• Record ID: K024261
• Device Name: DENTAL PROTECTOR
• Applicant: Dental Concepts, LLC
• Product Code: MQC · DE
• Decision Date: Mar 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Dental Concepts Bite Plate is indicated for protection against bruxism (nighttime teeth grinding) and jaw clenching during sleep, short-term pain relief from muscle spasm due to occlusal interference, and prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth by the temporalis muscle.

Device Story

Dental Concepts Bite Plate is a custom-fit, soft thermoplastic dental protector. Device acts as a physical barrier between posterior mandibular and maxillary teeth to mitigate effects of bruxism and jaw clenching. User heats the thermoplastic material to soften it, then molds it to the upper dental arch for a custom fit; can be trimmed for comfort. Used by patients during sleep. Provides a mechanical cushion to reduce muscle spasm and prevent chronic tension/TMJ syndrome. Benefits include protection of teeth from grinding damage and relief of associated jaw pain.

Clinical Evidence

No clinical data. Biocompatibility assessment performed on materials with satisfactory results.

Technological Characteristics

Composed of soft, formable thermoplastic resin. Form factor is a dental arch available in three sizes, trimmable. Principle of operation is mechanical barrier/cushioning via custom-molded thermoplastic fit. No energy source, software, or connectivity.

Indications for Use

Indicated for patients suffering from bruxism (nighttime teeth grinding) and jaw clenching during sleep, requiring short-term pain relief from muscle spasms due to occlusal interference, or seeking prevention of chronic tension and TMJ syndrome caused by chronic jaw clenching.

Predicate Devices

• Dr. Hays Bite Guard (K014079)

Submission Summary (Full Text)

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K024261

MAR 2 6 2003

# 510(k) Summary for the Dental Concepts Bite Plate

#### SPONSOR 1.

Dental Concepts LLC 650 From Road Paramus, NJ 07652

Contact Person: Michael Lesser, President Telephone: [phone]

March 5, 2003 Date Prepared:

#### 2. DEVICE NAME

None assigned at this time Proprietary Name: Common/Usual Name: Dental protector Classification Information:

Dental protectors have yet to be classified, but are proposed to be Class II devices, based on the recent classification of similar devices. Currently, predicate products are classified under the following classification name:

| Name | Product Code | 21 CFR Ref. | Panel |
|--------------------------|--------------|-------------|--------|
| Jaw Repositioning Device | LQZ | 872.5570 | Dental |

## PREDICATE DEVICES 3.

Dr. Hays Bite Guard, 510(k) No. K014079, cleared February 22, 2002

# DEVICE DESCRIPTION 4.

Dental Concepts' Bite Plate is a soft, comfortable, custom-fit protector intended to provide a barrier between the teeth for those patients who grind their teeth at night (bruxism). The product is shaped like a dental arch and is available in three sizes, but can be trimmed to fit more comfortably.

Dental Concepts Bite Plate Additional Information - K024261 March 13, 2003

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### ಳು INTENDED USE

The Dental Concepts Bite Plate is indicated for protection against bruxism (nighttime teeth grinding) and jaw clenching during sleep, short-term pain relief from muscle spasm due to occlusal interference, and prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth by the temporalis muscle.

# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE ર્ભ.

The Bite Plate is composed of a soft, formable clear upper material, made of a thermoplastic resin and a base material composed of a thermoplastic resin. When the product is heated and then cooled briefly, the upper material can be molded to fit to the upper teeth. The Dr. Hays Bite Guard is composed of a single thermoplastic resin that, like the Bite Plate, can be custom fit to the mouth. The products have slightly different dimensions, but the Bite Plate can be trimmed to fit the mouth more comfortably.

A biocompatibility assessment was performed on the materials of the Bite Plate with satisfactory results.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2003

Dental Concepts LLC C/O Mr. Michael Lesser Medical Device Consultant, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K024261

Trade/Device Name: Bite Plate Regulation Number: None Regulation Name: Dental Protector Regulatory Class: Unclassified Product Code: MQC Dated: March 5, 2003 Received: March 6, 2003

Dear Mr. Lesser:

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 - Mr. Lesser

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, "Misbranding 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/dsma/dsmamain.html

Sincerely vours,

Clus L
Susan Runner, DDS/MA

Interim 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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K024261

510(k) Number (if known): K024261

Bite Plate Device Name:

Indications for Use:

The Dental Concepts Bite Plate is indicated for protection against bruxism (nighttime teeth grinding) and jaw clenching during sleep, short-term pain relief from muscle spasm due to occlusal interference, and prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary tecth by the temporalis muscle.

(PLEASE DO NOT WRITE BELOW THIS I.INE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Reno

v. General Hospital.

510(k) Number. K024261

Dental Concepts Bite Plate Additional Information - K024261

科学学

March 13, 2003

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