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K Number
K171815
Device Name
Registrado Scan
Manufacturer
VOCO GmbH
Date Cleared
2017-11-15

(149 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

-Occlusal bite registration
-Fixing of face bow registrations

  • Location material for intraoral pin tracing templates
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) clearance letter for the device "Registrado Scan" does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance.

The document is a clearance letter stating that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method for a test set.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Results of a standalone algorithm performance study.
  7. The type of ground truth used.
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

This type of detailed performance data is typically found in the 510(k) submission itself, which is a much larger document not provided here. The clearance letter only confirms the regulatory decision based on that submission.

§ 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.