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K Number
K991489
Device Name
ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)
Manufacturer
HARRY J. BOSWORTH CO.
Date Cleared
1999-07-15

(78 days)

Product Code
ELW
Regulation Number
872.3660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
K991490
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Alginate Impression Material I mixed with water is used as a dental impression material.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for an alginate impression material, which is a dental device. It does not describe any acceptance criteria for an AI device, a study proving it meets those criteria, or any of the other details you've asked for regarding AI performance or ground truth establishment.

§ 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).