CUSTOM COMFORT NIGHTGUARD VERSION 2

K091660 · Den Tek Oral Care, Inc. · OBR · Jun 12, 2009 · DE

Device Facts

• Record ID: K091660
• Device Name: CUSTOM COMFORT NIGHTGUARD VERSION 2
• Applicant: Den Tek Oral Care, Inc.
• Product Code: OBR · DE
• Decision Date: Jun 12, 2009
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

DenTek's Custom Comfort Nightguard Version 2 is indicated for use 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

Custom Comfort Nightguard Version 2 is an over-the-counter, fully occlusive nightguard designed for self-use by individuals suffering from nocturnal bruxism. The device consists of a soft, formable material layer bonded to a non-formable hard base. The user heats the device and molds the soft material to their maxillary dentition to ensure retention; the hard base provides structural integrity to prevent bite-through and cushions occlusal surfaces. By acting as a physical barrier between upper and lower teeth, the device reduces dental wear and suppresses grinding noise. It is a mechanical, non-electronic device.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Fully occlusive nightguard; dual-layer construction with soft, heat-formable material and hard, non-formable base. Mechanical retention via custom molding to maxillary dentition. Non-electronic, no software, no energy source.

Indications for Use

Indicated for individuals experiencing bruxism or nighttime teeth grinding to reduce dental damage and prevent grinding noise. Over-the-counter use.

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

• DenTek Oral Care Inc.'s Custom Comfort Nightguard (K083400)
• DenTek Oral Care Inc.'s DenTek NightGuard (K063483)
• Dental Concepts, LLC's The Doctor's Nightguard Advanced Comfort (K073220)

Submission Summary (Full Text)

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K091660

#### 510(k) SUMMARY

JUN 1 2 2009

# DenTek Oral Care Inc.'s Custom Comfort Nightguard Version 2

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

Howard M. Holstein, Esq. Hogan & Hartson LLP 555 13th Street NW Washington, DC 20004 Phone: [phone] Facsimile: [phone]

Date Prepared: June 5, 2009

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

Custom Comfort Nightguard Version 2

DenTek Oral Care, Inc. 307 Excellence Way Maryville, TN 37801 [phone] Phone: Facsimile: [phone]

#### Common or Usual Name

Nightguard

### Classification Name

Mouthguard, Over-the-Counter

#### Classification Product Code

OBR

#### Predicate Devices

DenTek Oral Care Inc.'s Custom Comfort Nightguard (K083400) DenTek Oral Care Inc.'s DenTek NightGuard (K063483) Dental Concepts, LLC's The Doctor's Nightguard Advanced Comfort (K073220)

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# Purpose of the Special 510(k) notice.

The Custom Comfort Nightguard Version 2 is a modification to DenTek Oral Care Inc.'s Custom Comfort Nightguard (K083400) and DenTek Oral Care Inc.'s DenTek NightGuard (K063483).

#### Intended Use

DenTek's Custom Comfort Nightguard Version 2 is indicated for use 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 Custom Comfort Nightguard Version 2 is a fully occlusive nightguard, consisting of a soft, formable material, and non-formable base, which cushions the teeth. When heated and then briefly cooled, the formable material is molded to fit the user's maxillary dentition for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces.

### Substantial Equivalence

DenTek's Custom Comfort Nightguard Version 2 has the same intended use and similar indications, principles of operation, and technological characteristics as DenTek's Custom Comfort Nightguard. DenTek's NightGuard, and Dental Concepts' Doctor's Nightguard Advanced Comfort. The minor modifications made to the device do not raise any new questions of safety or effectiveness. Thus, the Custom Comfort Nightguard Version 2 is substantially equivalent to its predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### Public Health Service

JUN 1 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DenTek Oral Care, Incorporated C/O Mr. Howard M. Holstein Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteen Street, NW Washington, District of Columbia 20004

Re: K091660

Trade/Device Name: Custom Comfort Nightguard Version 2 Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR Dated: June 5, 2009 Received: June 9, 2009

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 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. 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); 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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.

Sarem Ruarer

Susan Runner, D.D.S. Acting 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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K091660

#### Indications for Use Statement

510(k) Number (if known):

Device Name: Custom Comfort Nightguard Version 2

Indications for Use:

The Custom Comfort Nightguard Version 2 is indicated for use 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 (Per 21 C.F.R. 801.109) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Posey

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

510(k) Number: K071660