SILICOATER MD

Cement, Dental

KULZER, INC.

The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Silicoater Md.

Pre-market Notification Details

Device IDK910719
510k NumberK910719
Device Name:SILICOATER MD
ClassificationCement, Dental
Applicant KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine,  CA  92718
ContactSharon Parker
CorrespondentSharon Parker
KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine,  CA  92718
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-20
Decision Date1991-04-29

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