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K Number
K972027
Device Name
ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
Manufacturer
ZHERMACK S.P.A.
Date Cleared
1997-07-16

(44 days)

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

Elite H-D impression products are vinyl polysiloxane dental impression materials intended to be used for making very accurate dental impressions. The resulting impressions are used to make plaster models of the teeth.

Device Description

Elite H-D Hydrophilic Vinyl Polysiloxane Impression Materials - Light Body / Normal Setting - Light Body / Fast Setting - Regular Body - Heavy Body

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding dental impression materials. It does not contain any information about acceptance criteria or a study that proves a device meets those criteria. Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on 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).