510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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S & C Polymer GmbH

ELMSHORN Schleswig-Holstein, DE

S & C POLYMER GMBH appears in FDA device records in ELMSHORN Schleswig-Holstein, DE. FDA records list 20 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
20
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 20 510(k) clearances for S & C Polymer GmbH between 1995 and 2009. The busiest year on record is 1999, with 5. The most recent is 2009, with 4.

Clearances by year, as a table
510(k) clearance decisions for S & C Polymer GmbH, by decision year
YearClearances
19951
19981
19995
20001
20015
20031
20041
20081
20094
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K091735DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANTEMASubstantially Equivalent
K083062ROOT CANAL XRKIFSubstantially Equivalent
K083766PHOGLASS CEMEMASubstantially Equivalent
K082115PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECTEMASubstantially Equivalent
K081702CARBOXYLATE CEM, PHOSPHATE CEMEMASubstantially Equivalent
K042614S&C-SELF ETCH PR-BONDKLESubstantially Equivalent
K031420S & C -BRACKET ADHESIVESDYHSubstantially Equivalent
K012767S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIALELWSubstantially Equivalent
K011277HARD RELINEREBISubstantially Equivalent
K011431RESIN CEMEMASubstantially Equivalent
K011064CLASSIC CEMEMASubstantially Equivalent
K010012LC PROVIFILLEBGSubstantially Equivalent
K002502CERAM-PRIMEKLESubstantially Equivalent
K991442LC MICROFILLEBFSubstantially Equivalent
K990108LC FLOWFILLEBFSubstantially Equivalent
K984483A-SOFT RELINEREBISubstantially Equivalent
K984097DC-COREEBFSubstantially Equivalent
K984484LC MICROHYBRIDEBFSubstantially Equivalent
K973201PROVI CEMENTEMASubstantially Equivalent
K951075S & C VINYL POLYSILOXANE IMPRESSION MATERIALELWSubstantially Equivalent

Registered establishments

FDA registered establishments for S & C Polymer GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96812103003667632S & C POLYMER GMBHROBERT-BOSCH-STRASSE 2, ELMSHORN Schleswig-Holstein 25335 DE2026and 4 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain