The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Ceram-prime.
| Device ID | K002502 |
| 510k Number | K002502 |
| Device Name: | CERAM-PRIME |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STR. 5 D-25335 Elmshorn, DE |
| Contact | Jurgen Engelbrecht |
| Correspondent | Jurgen Engelbrecht S & C POLYMER GMBH ROBERT-BOSCH-STR. 5 D-25335 Elmshorn, DE |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-14 |
| Decision Date | 2000-11-08 |