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K Number
K222435
Device Name
Renamel® Microhybrid ;Renamel® Flowable Microhybrid
Manufacturer
Cosmedent, Inc
Date Cleared
2022-10-11

(60 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

Renamel Microhybrid

  • · Anterior restorations (Class III and IV)
  • · Deep Class V restorations (cervical caries, root erosion, wedge-shaped defects)
  • · Restorations in the posterior region (Class I and II)
  • · Veneering of discolored teeth
  • · Closing of diastemas by vestibular veneering
  • · Repair of composite and ceramic veneers

Renamel Flowable Microhybrid

  • · Class V restorations
  • · Sealing margins
  • · Repairing pitted areas in hybrid restorations
  • · Small occlusal and lingual repairs
  • · In deep Class V restorations to block out shine through prior to overlay with Renamel Microfill or Renamel Microhybrid
Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for dental restorative materials (Renamel® Microhybrid and Renamel® Flowable Microhybrid). It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter confirms that the devices are substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) from this document.

§ 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.