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K Number
K013802
Device Name
FRC POSTEC
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2002-05-01

(167 days)

Product Code
ELR
Regulation Number
872.3810
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

FRC Postec is intended for use by dentists to give retention for reconstruction of endontically treated teeth

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Ivoclar Vivadent, Incorporated for their device, FRC POSTEC. This document is related to the regulatory approval of a medical device, specifically a root canal post, and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This type of regulatory submission (510(k)) focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies that define and meet specific acceptance criteria in the manner expected for new, novel devices or those undergoing a PMA (Premarket Approval) process.

Therefore, I cannot provide the requested information from the given text. The document does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. Information about MRMC comparative effectiveness studies.
  6. Details of standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is a regulatory approval letter based on substantial equivalence, not a detailed technical report or study protocol.

§ 872.3810 Root canal post.

(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(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.