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K Number
K980963
Device Name
HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)
Manufacturer
FOREMOST DENTAL MFG., INC.
Date Cleared
1998-05-11

(56 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

Honigum® Automix and Honigum® Quick are polysiloxane impression materials to be applied by the dental professional prior to fabrication of crowns, bridges and inlays for their patients.

Device Description

polysiloxane impression materials

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental impression material. It does not describe any acceptance criteria or a study proving that a device meets such criteria. It's a regulatory approval document confirming substantial equivalence to a predicate device, not a technical performance report.

Therefore, I cannot extract the requested information from this document.

§ 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).