COMPOSITE RESTORATION MATERIAL

K031721 · Milton Hodosh, M.D. · EBF · Sep 11, 2003 · Dental

Device Facts

• Record ID: K031721
• Device Name: COMPOSITE RESTORATION MATERIAL
• Applicant: Milton Hodosh, M.D.
• Product Code: EBF · Dental
• Decision Date: Sep 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

USED AS A Composite RESTORATIVE to REPAIR CARIOUS LESIONS MATERÍAL FOR VENEERING. AND DoTASSIum CONTA

Device Story

Composite restorative material used by dental professionals to repair carious lesions and perform veneering. Applied directly to tooth structure to restore form and function. Benefits include restoration of decayed or damaged teeth.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory classification and intended use.

Technological Characteristics

Tooth shade resin material; composite restorative; class II device (21 CFR 872.3690).

Indications for Use

Indicated for use as a composite restorative material to repair carious lesions and for veneering. Prescription use only.

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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## Public Health Service

SEP 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Milton Hodosh Milton Hodosh, D.M.D. 243 Elmwood Avenue Providence, Rhode Island 02907

Re: K031721

Trade/Device Name: Composite Restoration Material Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: May 29, 2003 Received: June 16, 2003

, :

Dear Dr. Hodosh:

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. Hodosh

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 yours,

Susan Runnes

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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## Indications for Use

**Page** of

S ! (k) Number (if known): ENTAL ComposiTE RESTURATIVE Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:

USED AS A Composite RESTORATIVE to REPAIR CARIOUS LESIONS MATERÍAL FOR VENEERING. AND DoTASSIum CONTA

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

Rei Mueln Sor MSN

Division Sion of Anesthesiolo Infe ontrol, De

510(k) Number: K031721

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-the-Counter Use

(Optional Format 1-2-96)