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K Number
K112044
Device Name
ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A
Manufacturer
ANAXDENT GMBH
Date Cleared
2012-01-26

(192 days)

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

anaxBLEND:

  • full or partial facing of fixed metal-based crowns and bridges;
  • anterior and posterior crowns;
  • inlays, onlays;
  • facing of removable combined restorations (telescopic/conical crowns and attachment retained dentures);
  • Characterization of dentures

anaxGUM:

  • Esthetic rehabilitation of gingival parts in case of dental restorations with severe bone loss;
  • Facing of the gingival area of removable combined restorations (telescopic/conical crowns and attachment-retained dentures);
  • Characterization of dentures

mock-up direct / mock-up direct flow:

  • mock-ups;
  • direct anterior and posterior fillings of the classes 1, 11, 111, and V (Black);
  • indirect restorations as inlays, onlays and veneers;
  • extended fissure sealing of molars and premolars;
  • core build-ups;
  • splinting of loose teeth;
  • shape and color corrections to improve the esthetic appearance
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria or a study proving that a device meets those criteria.

Instead, this document:

  • Identifies the device: anaxBLEND anaxGUM Mock-up direct / mock-up direct flow
  • States its classification: Tooth Shade Resin Material, Regulatory Class: II, Product Code: EBF
  • Confirms substantial equivalence to a predicate device, meaning it is considered as safe and effective as a legally marketed device.
  • Outlines the indications for use for each product name (anaxBLEND, anaxGUM, mock-up direct / mock-up direct flow).

To answer your request, I would need a different type of document, such as a clinical study report, a performance testing report, or a summary of safety and effectiveness data that describes specific acceptance criteria and the results of a study designed to meet them.

§ 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.