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K Number
K170896
Device Name
Admira Fusion x-base
Manufacturer
VOCO GmbH
Date Cleared
2017-06-29

(94 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
  • Base in class I and II cavities
  • Cavity lining under direct restorative materials in class I and II cavities
  • Small, non occlusal stress-bearing class I restorations according to minimally invasive filling therapy
  • Class III and V restorations
  • Extended fissure sealing
  • Undercut blockout
  • Repair of small enamel defects
  • Repair of small defects in aesthetic indirect restorations
  • Repair of temporary C&B-materials
  • Core build-up
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to VOCO GmbH regarding their device, Admira Fusion x-base. This document is a regulatory approval letter and an "Indications for Use Statement." It does not contain information about acceptance criteria, study methodologies, device performance data, sample sizes, or expert qualifications for testing.

Therefore, I cannot provide the requested information based on the input text. The document confirms the device's classification and lists its intended uses but does not detail the studies or data used to support its safety and effectiveness.

§ 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.