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K Number
K972101
Device Name
SOLITAIRE
Manufacturer
HERAEUS KULZER, INC.
Date Cleared
1997-09-29

(117 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Class I & II (Black) Cavities
  • Class V Fillings (Black)
  • Deciduous Tooth Reconstruction
  • Stump Rebuilding
Device Description

Solitaire is a light-curing, fluoride releasing radiopaque polyglas composite. Together with the Solid bond adhesive bonding system, it is composite. Together with the Still Come Can't

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental composite device called "Solitaire." It does not contain information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the provided text.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.