LogoFDA 510(k) Search
K Number
K994012
Device Name
TEMPOFIT, MODEL 02693
Manufacturer
DETAX GMBH & CO. KG
Date Cleared
2000-02-16

(82 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Material for making temporary crowns and bridges, self curing, fast setting, bis-acrylic-composite 2:1

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a dental material called "Tempofit," and a statement of indications for use.

This document does not contain any information about:

  • Acceptance criteria for a device.
  • A study that proves a device meets acceptance criteria.
  • Any of the specific details requested in your prompt (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, etc.).

The letter is simply an FDA approval notice indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications and general controls, but not performance study details.

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.