LogoFDA 510(k) Search
K Number
K162261
Device Name
CERAMAGE UP
Manufacturer
SHOFU DENTAL CORPORATION
Date Cleared
2017-01-11

(153 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
  • Fabrication of permanent & temporary indirect restorations
  • Crowns & Bridges for anterior and posterior restorations
  • Jacket crowns for anterior and posterior restorations
  • Inlays & Onlays
  • Laminate veneers
  • Implant superstructures
  • Intraoral & extraoral repairs of indirect restorations
Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Ceramage Up". This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/device validation. It solely confirms the substantial equivalence of the "Ceramage Up" device to legally marketed predicate devices for its stated indications for use.

Therefore, I cannot provide the requested information based on this document. The questions you've asked are typically relevant for AI/machine learning medical devices, which require specific studies to prove their performance. This document is for a dental material (Tooth Shade Resin Material), not an AI device.

§ 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.