ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)

Material, Impression

ZHERMACK S.P.A.

The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Elite H-d Hydrophilic Vinyl Polysiloxane Impression Materials (light Body/normal,light Body/fast Setting,regular Body,).

Pre-market Notification Details

Device IDK972027
510k NumberK972027
Device Name:ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
ClassificationMaterial, Impression
Applicant ZHERMACK S.P.A. 7527 WESTMORELAND AVE. St. Louis,  MO  63105
ContactEvan Dick
CorrespondentEvan Dick
ZHERMACK S.P.A. 7527 WESTMORELAND AVE. St. Louis,  MO  63105
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-02
Decision Date1997-07-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00883205107794 K972027 000
58033712562051 K972027 000
00883205032355 K972027 000
00883205032348 K972027 000
00883205032331 K972027 000
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00883205032300 K972027 000
00883205032294 K972027 000
00883205032287 K972027 000
00883205032270 K972027 000
00883205032263 K972027 000
00883205032256 K972027 000
58033712562105 K972027 000
58033712562167 K972027 000
58033712562198 K972027 000
00883205107787 K972027 000
00883205107770 K972027 000
00883205107763 K972027 000
00883205107756 K972027 000
00883205107732 K972027 000
00883205107725 K972027 000
00883205107718 K972027 000
00883205107701 K972027 000
00883205107695 K972027 000
00883205107688 K972027 000
00883205107671 K972027 000
00883205107664 K972027 000
00883205032249 K972027 000

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