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K Number
K163568
Device Name
SHOFU RESIN GLAZE
Manufacturer
Shofu Dental Corporation
Date Cleared
2017-08-16

(240 days)

Product Code
EBD
Regulation Number
872.3310
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

SHOFU RESIN GLAZE is indicated to temporarily glaze the following restoration surfaces:

  • Artificial resin teeth
  • Acrylic denture base materials
  • CAD/CAM PMMA materials
  • CAD/CAM hybrid ceramic materials
  • Indirect composite resins
  • Provisional materials
Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding a dental product called "Shofu Resin Glaze". This document does not contain information about acceptance criteria for device performance, the study that proves the device meets those criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given text. This document is a regulatory clearance letter, not a clinical study report or a technical performance evaluation.

§ 872.3310 Coating material for resin fillings.

(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.