DOCTOR'S NIGHTGUARD

K053580 · Dental Concepts, LLC · MQC · Mar 3, 2006 · DE

Device Facts

• Record ID: K053580
• Device Name: DOCTOR'S NIGHTGUARD
• Applicant: Dental Concepts, LLC
• Product Code: MQC · DE
• Decision Date: Mar 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Doctor's NightGuard is indicated for 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.

Device Story

Dental protector for nighttime bruxism; intended for over-the-counter use. Device consists of a soft, formable upper layer (ethylene and vinyl acetate copolymer) and a hard occlusal base (ethylene and methyl acrylate copolymer). User heats and cools the upper material to mold it to their upper teeth; hard base provides bite-through protection and shock absorption. Designed to reduce tooth damage and grinding noise. No electronic components or software.

Clinical Evidence

No clinical data or performance testing required for this 510(k) notice.

Technological Characteristics

Dental protector composed of two polymers: soft formable upper layer (ELVAX® resin, ethylene and vinyl acetate copolymer) and hard occlusal base (Elvaloy®, ethylene and methyl acrylate copolymer with 9% methyl acrylate). Mechanical device; no energy source, connectivity, or software.

Indications for Use

Indicated for protection against bruxism or nighttime teeth grinding in individuals requiring reduction of tooth damage and noise associated with grinding.

Predicate Devices

• BruxGuard (Dental Concepts)

Reference Devices

• Mouth Peace (Hollywood Products)
• Tension Reliever (GEM Scientific Products, Inc.)

Submission Summary (Full Text)

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K053580

#### MAR 3 2006 510(k) SUMMARY

# Dental Concepts The Doctor's® NightGuard™

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Hogan & Hartson, LLP 555 13th Street, N.W. Washington, D.C. 20004

Howard M. Holstein Contact:

[phone] Phone: [phone] Facsimile:

Date Prepared: December 22, 2005

### Name of Device and Name/Address of Sponsor

Doctor's® NightGuard™

Dental Concepts, LLC 650 From Road Paramus, NJ 07652

| Contact Person: | Michael Lesser, President |
|-----------------|---------------------------|
| Phone: | [phone] |
| Facsimile: | [phone] |

### Common or Usual Name

Dental Protector

#### Classification Name

Unclassified

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#### Predicate Devices

Dental Concepts BruxGuard Hollywood Products Mouth Peace GEM Scientific Products, Inc. Tension Reliever

### Intended Use / Indications for Use

The Doctor's NightGuard is indicated for 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.

#### Technological Characteristics

The Doctor's NightGuard is composed of a soft, formable clear upper material, made of ELVAX® resin, a copolymer of ethylene and vinyl acetate, and a hard occlusal base, which cushions the teeth. The base is composed of Elvaloy®, a copolymer of ethylene and methyl acrylate containing 9% methyl acrylate. When heated and then briefly cooled, the upper material can be molded to fit the user's upper teeth. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing. The shock absorbing polymer material cushions the teeth on all sides.

#### Performance Data

No performance data is required in support of this 510(k) notice.

#### Substantial Equivalence

The Doctor's NightGuard is as safe and effective as Dental Concepts' BruxGuard. The two devices are physically the same. The labeling for the Doctor's NightGuard has been revised to make it suitable for OTC use. Because the two devices are the same, the Doctor's NightGuard possesses the same technological characteristics and principles of operation and a similar intended use as the BruxGuard predicate device. The Doctor's NightGuard also has similar intended uses and indications as the Hollywood Products Mouth Peace and the GEM Scientific Products, Inc. Tension Reliever, which were sold over the counter, like the NightGuard. Thus, the Doctor's NightGuard is substantially equivalent.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, which is a traditional symbol of medicine and healing.

MAR 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dental Concepts Limited Liability Corporation C/O Mr. Howard M. Holstein Hogan & Hartson Limited Liability Partnership 555 Thirteenth Street, NW Washington DC 20004

Re: K053580

Trade/Device Name: Doctor's Nightguard Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MQC Dated: December 22, 2005 Received: December 22, 2005

Dear Mr. Holstein:

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. Howard M. Holstein

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 (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.

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/industry/support/index.html.

Sincerely yours,

Sim Runoor

Sea-Chin Liu, Ph.D.

7 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 Statement

K053580 510(k) Number (if known):__

Device Name: Doctor's® NightGuard™

Indications for Use:

The Doctor's NightGuard is indicated for 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 C.F.R. 801 Subpart D) AND/OR

Over The - Counter Use X (21 C.F.R. 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Suarez

or dogs General Huspi Juntal Lovices

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