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K Number
K180649
Device Name
BeautiCem Veneer Kit
Manufacturer
Shofu Dental Corporation
Date Cleared
2018-06-11

(90 days)

Product Code
EBF,EMA,KLE
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

Cementation of ceramic or composite resin laminate veneers and translucent inlays and onlays with a thickness of less than 2 mm

Device Description

Not Found

AI/ML Overview

This is an FDA communication regarding a 510(k) premarket notification for a dental product, the BeautiCem Veneer Kit. It is not a study document describing acceptance criteria or device performance. Therefore, I cannot extract the requested information from the provided text.

The document states that the FDA has reviewed the submission and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it has met the regulatory requirements for clearance, but the document does not provide details of specific performance criteria or a study that tested those criteria.

To elaborate on why the requested information cannot be found:

  • Acceptance Criteria and Reported Device Performance: This document does not contain a table of acceptance criteria or the performance metrics of the BeautiCem Veneer Kit. It confirms the regulatory clearance based on substantial equivalence.
  • Sample size and Data Provenance: Information regarding sample sizes for test sets, training sets, or data provenance (country, retrospective/prospective) is not present.
  • Expert Details and Ground Truth Establishment: There is no mention of experts, their qualifications, or how ground truth was established for any studies.
  • Adjudication Method: Adjudication methods are not discussed.
  • MRMC Comparative Effectiveness Study: There is no mention of an MRMC study or effect sizes of human readers with/without AI assistance, as this device is a dental material, not an AI diagnostic tool.
  • Standalone Performance: As above, this is not an AI algorithm, so standalone performance is not relevant.
  • Type of Ground Truth: The concept of "ground truth" (e.g., pathology, outcomes data) is typically associated with diagnostic or AI performance studies, which are not described here.
  • Sample Size for Training Set: Not applicable, as this is a dental material.
  • Ground Truth for Training Set: Not applicable.

This document is a regulatory approval letter, not a scientific study report.

§ 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.