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K Number
K161891
Device Name
HC Primer
Manufacturer
Shofu Dental Corporation
Date Cleared
2016-11-21

(133 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Priming of CAD/CAM hybrid ceramic restorations

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding a dental product named "Hc Primer." It pertains to the regulatory clearance of a material (Resin Tooth Bonding Agent) and not a medical device that would involve AI, imaging, or diagnostics, which are typically the subjects of studies with "acceptance criteria" and "device performance" in the context of AI/ML devices.

Therefore, the document does not contain any information about:

  • Acceptance criteria for an AI/ML device
  • Reported device performance in terms of metrics like sensitivity, specificity, or accuracy
  • Sample sizes for test or training sets
  • Data provenance
  • Ground truth establishment or number/qualification of experts
  • Adjudication methods
  • Multi-reader multi-case (MRMC) studies or effect sizes
  • Standalone algorithm performance

The questions posed are relevant to the regulatory submission of AI/ML-powered medical devices, specifically those involving diagnostic or prognostic capabilities based on image analysis or other data types. This document is a clearance for a chemical substance used in dental procedures.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.