The following data is part of a premarket notification filed by S & C Polymer Gmbh with the FDA for Lc Flowfill.
| Device ID | K990108 |
| 510k Number | K990108 |
| Device Name: | LC FLOWFILL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | S & C POLYMER GMBH ROBERT-BOSCH-STR. 5 D-25335 Elmshorn, DE |
| Contact | Jurgen Engelrecht |
| Correspondent | Jurgen Engelrecht S & C POLYMER GMBH ROBERT-BOSCH-STR. 5 D-25335 Elmshorn, DE |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-13 |
| Decision Date | 1999-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBIB752401 | K990108 | 000 |