The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Renew Ls-1.
| Device ID | K003317 |
| 510k Number | K003317 |
| Device Name: | RENEW LS-1 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Cindy Oris |
| Correspondent | Cindy Oris BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-24 |
| Decision Date | 2000-11-21 |