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K Number
K060293
Device Name
TEMPORARY CROWN AND BRIDGE MATERIAL
Manufacturer
DENTSPLY INTERNATIONAL, INC.
Date Cleared
2006-02-17

(11 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
K924830
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TEMPORARY CROWN AND BRIDGE MATERIAL is indicated for direct fabrication of TEMFORANT CROWN THD BRIDGE nlays, crowns or bridges used in indirect restorative procedures.

Device Description

The TEMPORARY CROWN AND BRIDGE MATERIAL is a two-component, methacrylate-based material. The volume mix of this automixed material is a 1:1 ratio. The unit dose delivery system matchui. "The votential risks associated with asepsis and the need for disinfection.

AI/ML Overview

I am sorry, but the provided text from the K060293 document primarily discusses the regulatory approval (510(k) summary) rather than a study detailing acceptance criteria and device performance. The document describes the device, its intended use, and technological characteristics, and then proceeds with the FDA's clearance letter.

There is no information within the provided text that describes:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for a test set or training set.
  • Data provenance (country of origin, retrospective/prospective).
  • Number or qualifications of experts for ground truth.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness study results.
  • Standalone algorithm performance.
  • Type of ground truth used (e.g., pathology, outcomes data).
  • How ground truth for a training set was established.

The document focuses on demonstrating substantial equivalence to a predicate device (Luxatemp Automix, K924830) based on material composition and intended use, rather than presenting a performance study with detailed statistical results against specific acceptance criteria.

Therefore, I cannot fulfill your request for details on acceptance criteria and a study proving the device meets them based on the provided input.

§ 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.