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K Number
K211259
Device Name
Renamel Bulkfill
Manufacturer
Cosmedent, Inc
Date Cleared
2021-06-24

(59 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. Direct Posterior Restorations (including occlusal surfaces)
  2. Replacement of individual cusps
  3. Base-liner under direct restorations.
  4. Restorations of deciduous teeth
  5. Class V restorations (cervical caries, root erosion, wedge-shaped defects)
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is an FDA clearance letter for a dental resin material, "Renamel Bulkfill". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding:

  • Acceptance criteria for a device performance study.
  • Details of a study proving the device meets acceptance criteria.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Number of experts or their qualifications for ground truth establishment.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance studies.
  • Type of ground truth used.
  • How ground truth for a training set was established.

This document is solely a regulatory clearance for a physical dental product (filling material), not a software or AI-driven diagnostic device that would typically undergo the types of studies you are asking about.

§ 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.