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K Number
K012160
Device Name
COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408
Manufacturer
PREMIER DENTAL PRODUCTS CO.
Date Cleared
2001-09-27

(78 days)

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

CompCore™ AF is an automix, fluoride releasing, resin composite material designed for the direct fabrication of core build-ups.

Device Description

CompCore™ AF is an automix, fluoride releasing, resin composite material designed for the direct fabrication of core build-ups.

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment relevant to the device "CompCore™ AF."

The document is a 510(k) premarket notification letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general information but does not include any study details or performance data as requested in your prompt.

§ 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.