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K Number
K150784
Device Name
Admira Fusion
Manufacturer
VOCO GMBH
Date Cleared
2015-07-02

(99 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Admira Fusion is intended for use as:

  • Class I to V restorations
  • Base in class I and II cavities
  • Reconstruction of traumatically damaged anteriors
  • Facetting of discoloured anteriors
  • Correction of shape and shade for improved aesthetic appearance
  • Locking, splinting of loose anteriors
  • Repairing veneers, small enamel defects and temporary C&B-materials
  • Extended fissure sealing
  • Restoration of deciduous teeth
  • Core build-up
  • Composite inlays
Device Description

Not Found

AI/ML Overview

I am sorry, but this document contains no information about the acceptance criteria or a study proving that the device meets them. This document is a 510(k) clearance letter from the FDA for a dental resin product called "Admira Fusion". It primarily communicates that the device has been found substantially equivalent to predicate devices and outlines regulatory obligations.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.