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K Number
K083195
Device Name
MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN
Manufacturer
LANG DENTAL MFG. CO., INC.
Date Cleared
2009-06-05

(219 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

LANG DENTAL TOOTH SHADE TEMPORARY CROWN AND BRIDGE ACRYLIC RESIN is intended for the fabrication of temporary crowns and bridges.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information about acceptance criteria or study data for device performance. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

  • Acceptance criteria and reported device performance.
  • Sample sizes, data provenance, or details of expert involvement for ground truth establishment.
  • Adjudication methods.
  • MRMC comparative effectiveness studies or standalone algorithm performance.
  • The type of ground truth used or details about training sets.

§ 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.