FLOWABLE HYBRID

Coating, Filling Material, Resin

COSMEDENT, INC.

The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Flowable Hybrid.

Pre-market Notification Details

Device IDK980298
510k NumberK980298
Device Name:FLOWABLE HYBRID
ClassificationCoating, Filling Material, Resin
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 CodeEBD  
CFR Regulation Number872.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-27
Decision Date1998-03-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D779701MWO0 K980298 000
D7797011A10 K980298 000
D7797011A20 K980298 000
D7797011A30 K980298 000
D7797011A40 K980298 000
D7797011B10 K980298 000
D7797011B20 K980298 000
D7797011B30 K980298 000
D7797011C20 K980298 000
D7797011C30 K980298 000
D7797011C40 K980298 000
D7797011CO0 K980298 000
D7797011D30 K980298 000
D7797011MI0 K980298 000
D779701A350 K980298 000
D77970110W0 K980298 000

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