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K Number
K233161
Device Name
BeautiLink SA
Manufacturer
Shofu Dental Corporation
Date Cleared
2023-09-28

(1 days)

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

Cementation of all-ceramic, composite and metal restorations
Post cementation

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 cement called "BeautiLink SA." It discusses regulatory aspects, general controls, and indications for use.

It does not contain:

  • A table of acceptance criteria and reported device performance.
  • Details about sample sizes, data provenance, or the nature of test sets (retrospective/prospective, country of origin).
  • Information on experts, ground truth establishment, or adjudication methods for any test or training sets.
  • Any mention of a Multi-Reader Multi-Case (MRMC) study or the effect size of AI assistance.
  • Details about standalone algorithm performance.
  • Information on the training set size or how its ground truth was established.

This document is a regulatory clearance, not a study report or technical specification outlining performance metrics and supporting validation 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.