The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for S & C -bracket Adhesives.
| Device ID | K031420 |
| 510k Number | K031420 |
| Device Name: | S & C -BRACKET ADHESIVES |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| Contact | Christian Boetttcher |
| Correspondent | Christian Boetttcher S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-05 |
| Decision Date | 2003-08-20 |
| Summary: | summary |