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K Number
K101215
Device Name
NUANCE
Manufacturer
DISCUS DENTAL, LLC
Date Cleared
2010-05-12

(12 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

Nuance Universal Composite:

  • Direct restorations of anterior or posterior teeth (Class I Class V) .
  • Diastema closures .
  • Intraoral repairs of fractured crowns/bridges ●

Nuance Posterior Composite:

  • Direct restorations of Class I and Class II cavities .

Nuance Flowable Composite:

  • Direct restorations of anterior or posterior teeth .
  • Cavity base/liner .
  • Intraoral repairs of fractured crowns/bridges .
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Discus Dental, LLC concerning dental composite materials. It is a regulatory document and does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information to fill in the table or answer the questions. The document is strictly about the FDA's decision on the substantial equivalence of the dental composites to legally marketed predicate devices.

§ 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.