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K Number
K022430
Device Name
ISO FUNCTIONAL
Manufacturer
GC AMERICA, INC.
Date Cleared
2002-10-18

(85 days)

Product Code
ELW
Regulation Number
872.3660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ISO Functional is used as a rebasing and relining impression material.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a dental impression material. This document does not contain information about acceptance criteria, study details, or performance metrics for a device regarding AI/ML.

Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, ground truth, or multi-reader multi-case studies because that information is not present in the provided text.

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).