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K Number
K201856
Device Name
Provicol QM Aesthetic
Manufacturer
VOCO GmbH
Date Cleared
2020-08-26

(51 days)

Product Code
EMA
Regulation Number
872.3275
Type
Special
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Provicol QM Aesthetic is intended for use as:

– Temporary luting of temporary restorations (crowns, bridges, inlays and onlays) - Temporary luting of permanent restorations (crowns, bridges, inlays and onlays)

Device Description

Not Found

AI/ML Overview

I am sorry, but after reviewing the provided document, I cannot find the specific information regarding acceptance criteria and the detailed study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the device "Provicol QM Aesthetic," indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.

While the letter mentions the device's indications for use, it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details about sample sizes for test sets, data provenance, or retrospective/prospective study design.
  3. Information on the number or qualifications of experts used for ground truth.
  4. Adjudication methods.
  5. Results of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
  6. Results of standalone (algorithm only) performance studies.
  7. The type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This type of detailed study information is typically found in the 510(k) submission itself, which is a much more extensive document than the clearance letter provided. The clearance letter confirms the regulatory status but doesn't detail the underlying performance studies.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.