INDURENT GEL

Material, Impression

ZHERMACK DENTAL PRODUCTION

The following data is part of a premarket notification filed by Zhermack Dental Production with the FDA for Indurent Gel.

Pre-market Notification Details

Device IDK935892
510k NumberK935892
Device Name:INDURENT GEL
ClassificationMaterial, Impression
Applicant ZHERMACK DENTAL PRODUCTION 7527 WESTMORELAND AVE. St. Louis,  MO  63105
ContactEvan C Dick, Ph.d.
CorrespondentEvan C Dick, Ph.d.
ZHERMACK DENTAL PRODUCTION 7527 WESTMORELAND AVE. St. Louis,  MO  63105
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-12
Decision Date1995-10-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
68033712561150 K935892 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.