The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for A-soft Reliner.
| Device ID | K984483 |
| 510k Number | K984483 |
| Device Name: | A-SOFT RELINER |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-16 |
| Decision Date | 1999-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBIB738101 | K984483 | 000 |