CARBOXYLATE CEM, PHOSPHATE CEM

Cement, Dental

S & C POLYMER GMBH

The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Carboxylate Cem, Phosphate Cem.

Pre-market Notification Details

Device IDK081702
510k NumberK081702
Device Name:CARBOXYLATE CEM, PHOSPHATE CEM
ClassificationCement, Dental
Applicant S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn,  DE D-25335
ContactChristian Boettcher
CorrespondentChristian Boettcher
S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn,  DE D-25335
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-17
Decision Date2008-09-05
Summary:summary

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