(377 days)
Gutta percha is inserted into rout canal following root canal preparation.
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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a device named "TGP" (Gutta Percha). It confirms the device's substantial equivalence to legally marketed predicate devices.
This document does not contain any information about:
- Acceptance criteria for a device's performance.
- Any study that proves the device meets acceptance criteria.
- Sample sizes for test sets or training sets.
- Data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Multi-reader multi-case comparative effectiveness studies.
- Standalone algorithm performance studies.
- Types of ground truth used.
Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about a study, as this information is not present in the provided 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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Page 2 - Mr Martin
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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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Page 1 of 1
510 (k) Number (K051573):_____________________________________________________________________________________________________________________________________________________
Device Name: TGP
Indications for Use:
Gutta percha is inserted into rout canal following root canal preparation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Swoon Purve
()) of Anda Lesiology, General Hospital, n Control Bental Devices
KC51573
§ 872.3850 Gutta percha.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.