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K Number
K023035
Device Name
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2002-12-02

(81 days)

Product Code
ELM
Regulation Number
872.3590
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

SR VivoTAC/SR OrthoTAC are radiopaque denture teeth intended to be used for determining the future placement, location and angulation of dental implants. The decemining the rature placements to se utilized to lengthen the cervical region so that the entire length of the tooth can be made of radiopaque material.

Device Description

SR VivoTAC, Modifier Monomer & Polymer

AI/ML Overview

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental device called "SR VivoTAC/SR OrthoTAC, Modifier Monomer & Polymer."

The letter primarily:

  • Confirms that the device is substantially equivalent to legally marketed predicate devices.
  • Outlines post-market regulatory requirements (e.g., registration, listing, GMP, labeling).
  • States the intended use of the device: "radiopaque denture teeth intended to be used for determining the future placement, location and angulation of dental implants."

It does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details on sample sizes, data provenance, or ground truth establishment for any study.
  3. Information on expert involvement, adjudication methods, or MRMC studies.
  4. Data on standalone algorithm performance.
  5. Information about training sets.

Therefore, I cannot fulfill your request based on the provided text.

§ 872.3590 Preformed plastic denture tooth.

(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special 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.