ANTIBACTERIAL GUTTA PERCHA

K971641 · Dr. Howard Martin, P.A. · EKM · Jul 21, 1997 · Dental

Device Facts

• Record ID: K971641
• Device Name: ANTIBACTERIAL GUTTA PERCHA
• Applicant: Dr. Howard Martin, P.A.
• Product Code: EKM · Dental
• Decision Date: Jul 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3850
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Indications for Use

For use in the final filling of prepared root canals in adult or decidious teeth when antibacterial activity is desired in the final filling agont. Used to promote healing effects and to help provent bacterial contamination of the canal. A root canal filler with antibacterial properties indicated in cases whore antibacterial properties coupled with excellent physical characteristics for complete filling of the root canal are needed.

Device Story

Antibacterial Gutta Percha is a dental material used for the final filling of prepared root canals. It functions as a root canal obturation agent that incorporates antibacterial properties to assist in healing and prevent bacterial contamination within the canal. The device is intended for use by dental professionals during endodontic procedures. It provides the physical characteristics necessary for complete filling of the root canal space while simultaneously delivering an antibacterial effect to the treated area.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Root canal filling material containing antibacterial agents. Formulated for physical properties required for complete canal obturation.

Indications for Use

Indicated for final filling of prepared root canals in adult or deciduous teeth requiring antibacterial properties to promote healing and prevent bacterial contamination.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kyle H. Sibinovic, Ph.D. Agent Dr. Howard Martin, P.A. C/O Shaldra, Incorporated 7613 Carteret Road Bethesda, Maryland 20817

JUL 21 1997

Re : K971641 Antibacterial Gutta Percha Trade Name: Regulatory Class: I Product Code: EKM May 1, 1997 Dated: Received: May 2, 1997

Dear Dr. Sibinovic:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. प्र substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Sibinovic

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/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 Radioloqical Health

Enclosure

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## 510 (k) Number (if known): K971641

## Device Name: Antibacterial Gutta Percha

Indications for Use: For use in the final filling of prepared root canals in adult or decidious teeth when antibacterial activity is desired in the final filling agont. Used to promote healing effects and to help provent bacterial contamination of the canal. A root canal filler with antibacterial properties indicated in cases whore antibacterial properties coupled with excellent physical characteristics for complete filling of the root canal are needed.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Olf) Division of Dental, and General Hosal 510(k) Number

Prescription Use ﻟﺴﺎ (Per 21 CFR801 109)

C

Over-The-Counter Use (Optional Fomat 1-2-96)

OR