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Data / Medical devices / Germany / S & C Polymer GMBH

S & C Polymer GMBH: FDA-registered device maker in ELMSHORN Schleswig-Holstein, Germany, 28 510(k) clearances

S & C Polymer GMBH is registered with the FDA (registration 9681210) in ELMSHORN Schleswig-Holstein, Germany. It lists 14 device types. The FDA files 28 510(k) clearances under its listings, the newest dated July 6, 2022. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch S & C Polymer GMBH
FDA registration number
9681210
FEI number
3003667632
Address
Robert-Bosch-Strasse 2, ELMSHORN Schleswig-Holstein, Germany, 25335
Owner or operator
S & C POLYMER GMBH (9019395)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed
June 17, 1999
Registered through
2027

Devices it lists

DeviceProduct codeClassRoleSource
Adhesive, Bracket And Tooth Conditioner, ResinDYH2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Contract manufacturer, Manufactureraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cement, DentalEMA2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Liner, Cavity, Calcium HydroxideEJK2Contract manufacturer, Manufactureraccessdata.fda.gov
Material, ImpressionELW2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Contract manufacturer, Manufactureraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Resin, Denture, Relining, Repairing, RebasingEBI2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Resin, Root Canal FillingKIF2Contract manufacturer, Manufactureraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Contract manufactureraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 6, 2022K221033UniPrime A, UniPrime E, UniPrime E/CKLESubstantially EquivalentS&C Polymer Silicon- Und Composite Spezialitäten GmbHaccessdata.fda.gov
November 20, 2020K202413LC ResinCal PCEJKSubstantially EquivalentS&C Polymer Silicon- Und Composite Spezialitaten GmbHaccessdata.fda.gov
July 3, 2019K182780XP CompositeEBFSubstantially EquivalentS&C Polymer Silicon- Und Composite Spezialitaeten GmbHaccessdata.fda.gov
April 22, 2019K182778LC GLOSSFILL XREBFSubstantially EquivalentS&C Polymer Silicon- Und Composite Spezialitaeten GmbHaccessdata.fda.gov
April 14, 2015K141047LC CALCIUMHYDROXIDE LINEREJKSubstantially EquivalentS&C Polymer Silicon- Und Composite Spezialitaetenaccessdata.fda.gov
July 24, 2013K130125MTA CEMENTSKIFSubstantially EquivalentS&C Polymer Silicon- Und Composite Spezialitaetenaccessdata.fda.gov
September 25, 2009K091735DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANTEMASubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
March 12, 2009K083062ROOT CANAL XRKIFSubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
January 15, 2009K082115PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECTEMASubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
September 5, 2008K081702CARBOXYLATE CEM, PHOSPHATE CEMEMASubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
November 22, 2004K042614S&C-SELF ETCH PR-BONDKLESubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
August 20, 2003K031420S & C -BRACKET ADHESIVESDYHSubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
November 1, 2001K012767S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIALELWSubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
June 26, 2001K011277HARD RELINEREBISubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
June 11, 2001K011431RESIN CEMEMASubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
May 17, 2001K011064CLASSIC CEMEMASubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
February 14, 2001K010012LC PROVIFILLEBGSubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
November 8, 2000K002502CERAM-PRIMEKLESubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
November 2, 1999K992001TRAY-LINKELWSubstantially EquivalentSilicon-Und Composite Spezialitaten GmbHaccessdata.fda.gov
July 9, 1999K991450ETCHING GELEBFSubstantially EquivalentSilicon-Und Composite Spezialitaten GmbHaccessdata.fda.gov
June 3, 1999K991442LC MICROFILLEBFSubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
March 9, 1999K990108LC FLOWFILLEBFSubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
February 18, 1999K984483A-SOFT RELINEREBISubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
February 9, 1999K984097DC-COREEBFSubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
January 20, 1999K984484LC MICROHYBRIDEBFSubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
June 5, 1998K973201PROVI CEMENTEMASubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
April 18, 1996K960938PROV-KBEBGSubstantially EquivalentSilicon-Und Composite Spezialitaten GmbHaccessdata.fda.gov
March 31, 1995K951075S & C VINYL POLYSILOXANE IMPRESSION MATERIALELWSubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov

Compare with other makers

Updated July 6, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.