RENAMELIZE POLISHING PASTE

Agent, Polishing, Abrasive, Oral Cavity

COSMEDENT, INC.

The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Renamelize Polishing Paste.

Pre-market Notification Details

Device IDK862912
510k NumberK862912
Device Name:RENAMELIZE POLISHING PASTE
ClassificationAgent, Polishing, Abrasive, Oral Cavity
Applicant COSMEDENT, INC. 5419 NORTH SHERIDAN RD. Chicago,  IL  60640
ContactMichael O'malley
CorrespondentMichael O'malley
COSMEDENT, INC. 5419 NORTH SHERIDAN RD. Chicago,  IL  60640
Product CodeEJR  
CFR Regulation Number872.6030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-01
Decision Date1986-08-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D7799061010 K862912 000
D7799060000 K862912 000
EDEL9061010 K862912 000
EDEL9060000 K862912 000

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