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K Number
K243621
Device Name
Evoblock, Perléon
Manufacturer
Evoden Indústria Comércio Importação e Exportação
Date Cleared
2025-04-22

(151 days)

Product Code
EBG,EBI
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Indication for use:

  • Temporary anterior and posterior crowns;
  • Implant and abutment supported prosthetics;
  • Partial, complete and hybrid denture prosthetics (base and teeth).
Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter pertains to dental materials (Temporary Crown And Bridge Resin) and does not contain any information about an AI/ML medical device, its acceptance criteria, or the study that proves the device meets those criteria.

Therefore, I cannot extract the requested information regarding:

  • Acceptance Criteria Table: There is no mention of performance metrics like sensitivity, specificity, or AUC.
  • Sample Size and Data Provenance: No details about test sets, training sets, countries of origin, or retrospective/prospective studies.
  • Expert Ground Truth: No information about the number or qualifications of experts or how ground truth was established.
  • Adjudication Method: No mention of 2+1, 3+1, or any other adjudication process.
  • MRMC Study: No indication of a multi-reader, multi-case comparative effectiveness study or related effect sizes.
  • Standalone Performance: No data on the algorithm's performance without human intervention.
  • Type of Ground Truth: No mention of pathology, outcomes data, or expert consensus.
  • Training Set Sample Size and Ground Truth Establishment: No information provided.

The document is solely a regulatory approval for a physical dental product, not a software or AI/ML device requiring performance evaluation against clinical ground truth.

§ 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.