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K Number
K230877
Device Name
Admira Fusion 5
Manufacturer
VOCO GmbH
Date Cleared
2023-07-13

(105 days)

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

This is an FDA clearance letter for a dental material (Admira Fusion 5), not a medical device that uses AI or requires a study with specific acceptance criteria related to algorithm performance. Therefore, the provided text does not contain the information needed to answer the questions about acceptance criteria, study design, ground truth, or expert involvement as described in your prompt.

The document is a 510(k) premarket notification clearance letter, which confirms that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements for dental materials.

To answer your questions, I would need a document that describes the clinical performance or validation study of a specific medical device, especially one involving an AI algorithm.

§ 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.