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K Number
K151956
Device Name
Admira Fusion x-tra
Manufacturer
VOCO GMBH
Date Cleared
2015-10-20

(97 days)

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

Admira Fusion x-tra is intended for use as: - Class I and II posterior restorations - Base in class I and II cavities - Class V restorations - 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

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental resin material. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Such details would typically be found in the 510(k) submission document itself, not in the clearance letter.

Therefore, I cannot extract the requested information from the provided text.

§ 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.