The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Hard Reliner.
| Device ID | K011277 |
| 510k Number | K011277 |
| Device Name: | HARD RELINER |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| Contact | Jurgen Engelbrecht |
| Correspondent | Jurgen Engelbrecht S & C POLYMER GMBH ROBERT-BOSCH-STRASSE 5 Elmshorn, DE D-25335 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-26 |
| Decision Date | 2001-06-26 |