EU → North America Device Access

S & C Polymer, Silicon- und Composite Spezialitäten GmbH

DE-MF-000005270 · Germany · Elmshorn

S & C Polymer, Silicon- und Composite Spezialitäten GmbH is registered in the European database on medical devices as a manufacturer, with 108 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa108

Most frequent device types declared: LC Microhybrid.

Among these devices, 92 are declared implantable.

Catalogue references include 66055527, R20501, R20602, S004414, TBI12710, TBI15147.

European nomenclature codes declared: Q01010103, Q01020605, Q01020102, Q01010104, Q01010106, Q01010201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED108
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryS & C POLYMER SILICONE UND COMPOSITE SPEZIALITATEN GMBH

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record19
Currently active0
Class 2 devices3
Class 3 devices16
First licensed2007-06-22

Licence types: Device Group Family (10), System (4), Device Family (3), Single Device (2).

Licensed under: LC MICROHYBRID, LC FLOWABLE MICROHYBRID, CORE BUILD-UP MATERIALS, PROVI KB TEMPORARY CROWN AND BRIDGE MATERIALS, PR.-BOND, LC ETCHBOND DENTAL ADHESIVES, PROVI CEM NE PLUS (EUGENOL FREE TEMPORARY CEME.

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