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K Number
K193553
Device Name
VarseoSmile Temp
Manufacturer
BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG
Date Cleared
2020-05-18

(150 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

VarseoSmile Temp resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral light-curing equipment.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental resin product ("VarseoSmile Temp"). It outlines the regulatory clearance status, general controls provisions, and indications for use of the device.

However, it does not include any details about:

  • Acceptance criteria for device performance (beyond general regulatory compliance)
  • Specific "device performance" metrics or reported results
  • Sample sizes used for testing
  • Data provenance (country of origin, retrospective/prospective)
  • Number or qualifications of experts
  • Adjudication methods
  • Multi-reader multi-case (MRMC) studies
  • Standalone algorithm performance
  • Type of ground truth used
  • Training set sample size or how its ground truth was established

The document primarily focuses on the administrative and regulatory aspects of the device's clearance.

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.