TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)

K051573 · Dr. Howard Martin, P.A. · EKM · Jun 26, 2006 · Dental

Device Facts

• Record ID: K051573
• Device Name: TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
• Applicant: Dr. Howard Martin, P.A.
• Product Code: EKM · Dental
• Decision Date: Jun 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3850
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

Gutta percha is inserted into rout canal following root canal preparation.

Device Story

TGP is a gutta percha device used in endodontic procedures. It is inserted into the root canal by a dentist or endodontist following root canal preparation to fill and seal the canal space. The device functions as a filling material to prevent reinfection of the root canal system.

Clinical Evidence

No clinical data provided; device is a standard dental material.

Technological Characteristics

Gutta percha material; used as a root canal filling point/material. Standard dental endodontic material.

Indications for Use

Indicated for use in root canal obturation following root canal preparation.

Regulatory Classification

Identification

Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.

Submission Summary (Full Text)

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JUN 2 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Howard Martin, P.A. C/O Dr. Kyle H. Sibinovic Agent Shaldra, Incorporated 4327 Reels Mill Road Frederick, Maryland 21704

Re: K051573

Trade/Device Name: TGP Regulation Number: 872.3850 Regulation Name: Gutta Percha Regulatory Class: I Product Code: EKM Dated: May 10, 2006 Received: May 12, 2006

Dear Dr. Martin:

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,

ff your device is classified (see above) into either class II (Special Controls) or class HI (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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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 cntitled, "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 vours.

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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510 (k) Number (K051573):_____________________________________________________________________________________________________________________________________________________

Device Name: TGP

Indications for Use:

Gutta percha is inserted into rout canal following root canal preparation.

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Swoon Purve

()) of Anda Lesiology, General Hospital, n Control Bental Devices

KC51573