STERNOMEGA COMPOMER CEMENT

Cement, Dental

STERNGOLD/IMPLAMED

The following data is part of a premarket notification filed by Sterngold/implamed with the FDA for Sternomega Compomer Cement.

Pre-market Notification Details

Device IDK982895
510k NumberK982895
Device Name:STERNOMEGA COMPOMER CEMENT
ClassificationCement, Dental
Applicant STERNGOLD/IMPLAMED 50 BREWSTER ST. Pawtucket,  RI  02860
ContactPamela Papineau
CorrespondentPamela Papineau
STERNGOLD/IMPLAMED 50 BREWSTER ST. Pawtucket,  RI  02860
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-17
Decision Date1998-10-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EDMG2120351 K982895 000

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