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K Number
K210412
Device Name
Pac-Dent Ceramic Nanohybrid Resin
Manufacturer
Pac-Dent, Inc.
Date Cleared
2021-07-26

(165 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Pac-Dent Ceramic Nanohybrid Resin is indicated as a permanent restorative for both anterior restorations, including occlusal surfaces. It is used for fabrications such as inlays, onlays, veneers and full crown restorations.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental material (Pac-Dent Ceramic Nanohybrid Resin). It does not contain information about an AI/ML-based medical device. Therefore, I cannot extract the information required to answer your questions about acceptance criteria and study proving device performance for an AI/ML device.

The provided text only discusses:

  • The FDA's review and determination of substantial equivalence for a dental resin material.
  • Regulatory information regarding device registration, labeling, good manufacturing practices, and adverse event reporting for this type of medical device.
  • Indications for Use for the dental resin.

To answer your request, I would need a document related to the clearance or approval of an AI/ML-based medical device.

§ 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.