LogoFDA 510(k) Search
K Number
K043119
Device Name
AMELOGEN PLUS
Manufacturer
ULTRADENT PRODUCTS, INC.
Date Cleared
2004-12-17

(37 days)

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

The Amelogen plus is a tooth shade resin composite material [bisphenol-A, glycidy] methacrylate (Bis-GMA) based] to be used for posterior and anterior tooth restoration.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental resin material named "Amelogen Plus." It confirms the device's substantial equivalence to a predicate device but does not detail any performance study, acceptance criteria, or related metadata.

§ 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.