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K Number
K152471
Device Name
CAPO BULK FILL
Manufacturer
SCHUETZ DENTAL GMBH
Date Cleared
2016-08-04

(339 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
  • Fillings with layer thicknesses up to 4 mm in Black's class I and II cavities
  • Cavity lining - as a first (bottom) layer in Black's class I and II cavities
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental material (Capo Bulk Fill), not an AI/ML device. Therefore, it does not contain information about acceptance criteria or studies related to AI/ML device performance. The document describes the regulatory classification and indications for use of a tooth shade resin material.

As such, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device from this text.

§ 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.