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K Number
K031439
Device Name
ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
Manufacturer
HARRY J. BOSWORTH CO.
Date Cleared
2003-10-02

(149 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

Alginate Impression Material III (Fast & Regular Set) with water is used as dental impression material.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for an Alginate Impression Material III (Fast & Regular). It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

Therefore, I cannot fulfill your request with the provided input. The document is a regulatory approval letter, not a technical report or study summary.

§ 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).