LogoFDA 510(k) Search
K Number
K051573
Device Name
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
Manufacturer
DR. HOWARD MARTIN, P.A.
Date Cleared
2006-06-26

(377 days)

Product Code
EKM
Regulation Number
872.3850
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

Not Found

AI/ML Overview

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.

§ 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.