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K Number
K190453
Device Name
VisCalor bulk
Manufacturer
VOCO GmbH
Date Cleared
2019-04-11

(45 days)

Product Code
EBF
Regulation Number
872.3690
Type
Special
Panel
DE
Reference & Predicate Devices
K012345,K987654
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Class I and II posterior restorations
  • Base in class I and II cavities
  • Class V restorations
  • Locking, splinting of loose teeth
  • Repairing veneers, enamel defects and temporary C&B-materials
  • Extended fissure sealing
  • Restoration of deciduous teeth
  • Core build-up
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter for a dental device called VisCalor Bulk. It contains information related to the device's indications for use and regulatory classification. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information. The text is a regulatory document and not a clinical study report or technical specification document detailing performance metrics.

§ 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.