Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681210

FEI Number

3003667632

Entity Name

S & C POLYMER GMBH

City/State/Country

ELMSHORN Schleswig-Holstein, DE

Establishment Address

ROBERT-BOSCH-STRASSE 2, ELMSHORN Schleswig-Holstein 25335, DE

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

S & C POLYMER GMBH (Owner Number: 9019395)

Owner / Operator Contact Address

ROBERT-BOSCH-STRASSE 2, --, ELMSHORN, DE-SH D-25335, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K012767

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMA	Cement, Dental	Dental	Class 2	872.3275	2009-10-17
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2020-02-13
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2025-12-10
EMA	Cement, Dental	Dental	Class 2	872.3275	2017-02-10
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2017-02-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-03-08
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2023-03-08
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2016-09-01
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2013-07-29
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-09-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-02-21
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2008-02-06
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-02-13
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-02-21
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-02-21
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-02-21
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2008-02-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-07-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2022-07-07
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-02-21
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2020-11-26
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2008-02-21
ELW	Material, Impression	Dental	Class 2	872.3660	2008-02-21
ELW	Material, Impression	Dental	Class 2	872.3660	2008-02-21

Official Correspondent

No official correspondent registered.

US Agent Details

Edward Spehar Email: aorsley@outlook.com Phone: (908) 5533196

Related Public Records

Same Entity

S & C POLYMER GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681210. Last updated year: 2026. Please use registration number 9681210 when referencing this establishment in official correspondence.