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K Number
K111958
Device Name
TETRIC EVOCERAM BULK FILL
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2011-10-14

(95 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

Restoration of Deciduous teeth Restorations in the posterior region (Classes I and ii) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Extended fissure sealing in molars and premolars

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a dental filling material (Tetric EvoCeram Bulk Fill). It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document discusses:

  • The FDA's determination of substantial equivalence for the dental material.
  • Regulatory classifications and requirements for medical devices.
  • Indications for use for the Tetric EvoCeram Bulk Fill material (restoration of deciduous teeth, posterior restorations (Classes I and II), Class V restorations, and extended fissure sealing).

In summary, the provided text does not contain the information necessary to answer your request about acceptance criteria and device performance evaluation for an AI/ML product.

§ 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.