PRIME-DENT HEMA DESENSITIZER

K013970 · Prime Dental Manufacturing, Inc. · EBF · Feb 19, 2002 · Dental

Device Facts

• Record ID: K013970
• Device Name: PRIME-DENT HEMA DESENSITIZER
• Applicant: Prime Dental Manufacturing, Inc.
• Product Code: EBF · Dental
• Decision Date: Feb 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prime-Dent® Hema Desensitizer is used by Dentists to seal dentinal tubules in the tooth cavity preparation or sensitive root surfaces. Prime-Dent® Hema Desensitizer is also used as a wetting agent prior to bonding resin fillings and composites.

Device Story

Prime-Dent Hema Desensitizer is a dental material applied by dentists to tooth surfaces. It functions by sealing dentinal tubules to reduce sensitivity and acts as a wetting agent to facilitate the bonding of resin fillings and composites. The device is applied directly to the tooth structure during restorative procedures. It benefits patients by mitigating dentin hypersensitivity and improving the clinical performance of dental adhesive restorations.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental sealant/desensitizing agent containing HEMA (2-hydroxyethyl methacrylate). Applied topically to dentin surfaces. Non-electronic, chemical-based dental material.

Indications for Use

Indicated for use by dentists to seal dentinal tubules in tooth cavity preparations or sensitive root surfaces, and as a wetting agent prior to bonding resin fillings and composites.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 9 2002

Mr. Rolando Marasigan Vice President of Manufacturing Prime Dental Manufacturing, Incorporated 3735 West Belmont Avenue Chicago, Illinois 60618

Re: K013970

Trade/Device Name: Prime-Dent Hema Desensitizer Regulation Number: 872.3260 Regulation Name: Sealant Regulatory Class: II Product Code: LBH Dated: November 28, 2001 Received: December 3, 2001

### Dear :

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.

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.

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#### Page 2 - Mr. Marasigan

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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K013970

## Indications for Use

Prime-Dent® Hema Desensitizer is used by Dentists to seal dentinal tubules in the tooth Prime-Dent® Hema Desensitizer is used or Delitise to other Desensitizer is also
cavity preparation or sensitive root surfaces. Prime-Dent® Hema Desensitizer is also cavity preparation of sensitive root surfaces. I stillings and composites.
used as a wetting agent prior to bonding resin fillings and composites.

Susan Rungen

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