CLASSIC 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 Classic Cem.

Pre-market Notification Details

Device IDK011064
510k NumberK011064
Device Name:CLASSIC CEM
ClassificationCement, Dental
Applicant S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn,  DE D-25335
ContactJurgen Engelbrecht
CorrespondentJurgen Engelbrecht
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 Received2001-04-06
Decision Date2001-05-17

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