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K Number
K153177
Device Name
Admira Fusion Flow
Manufacturer
VOCO GMBH
Date Cleared
2016-06-30

(240 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 Flow is intended for use as:

  • Filling of small cavities and extended fissure sealing
  • Blocking out undercuts
  • Lining or coating cavities
  • Fillings of class III V cavities
  • Repairing fillings, veneers and temporary restorations
  • Luting translucent prosthetic pieces
  • Locking, splinting of loose teeth
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary for a dental device (Admira Fusion Flow) and does not contain information about acceptance criteria or a study proving its performance against such criteria. The document is an FDA clearance letter confirming substantial equivalence to a predicate device, along with the device's indications for use.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details from this document.

§ 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.