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K Number
K231591
Device Name
V-Print c&b temp
Manufacturer
VOCO GmbH
Date Cleared
2023-07-31

(60 days)

Product Code
POW,EBG
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Temporary crowns and bridges
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a dental device (V-Print c&b temp), which primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

It does not include details about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number of experts or their qualifications for establishing ground truth.
  4. Adjudication methods.
  5. MRMC comparative effectiveness studies or effect sizes.
  6. Standalone algorithm performance.
  7. Type of ground truth used (e.g., pathology, outcomes).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This kind of detailed performance and study information is typically found in the 510(k) submission summary or in a separate study report, neither of which is present in the provided text.

§ 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.