The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Renew Ls-2.
| Device ID | K003361 |
| 510k Number | K003361 |
| Device Name: | RENEW LS-2 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Cyndy Oris |
| Correspondent | Cyndy 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 | 2000-10-27 |
| Decision Date | 2000-11-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20810111541873 | K003361 | 000 |
| D757H721A1P1 | K003361 | 000 |
| D757H721A20 | K003361 | 000 |
| D757H721A2P1 | K003361 | 000 |
| D757H721A30 | K003361 | 000 |
| D757H721A350 | K003361 | 000 |
| D757H721A35P1 | K003361 | 000 |
| D757H721A3P1 | K003361 | 000 |
| D757H721B10 | K003361 | 000 |
| D757H721B1P1 | K003361 | 000 |
| D757H721A10 | K003361 | 000 |
| D757H722B10 | K003361 | 000 |
| 10810111541821 | K003361 | 000 |
| 10810111541838 | K003361 | 000 |
| 10810111541845 | K003361 | 000 |
| 20810111541866 | K003361 | 000 |
| 10810111541814 | K003361 | 000 |
| 10810111541807 | K003361 | 000 |
| D757H722A10 | K003361 | 000 |
| D757H722A20 | K003361 | 000 |
| D757H722A350 | K003361 | 000 |
| D757H722A1P1 | K003361 | 000 |
| D757H722A2P1 | K003361 | 000 |
| D757H722A30 | K003361 | 000 |
| D757H722C4P1 | K003361 | 000 |
| D757H722D30 | K003361 | 000 |
| D757H722D3P1 | K003361 | 000 |
| D757H722A1F0 | K003361 | 000 |
| D757H722A2F0 | K003361 | 000 |
| D757H722C2F0 | K003361 | 000 |
| D757H722A2S0 | K003361 | 000 |
| D757H722A35F0 | K003361 | 000 |
| D757H722A3F0 | K003361 | 000 |
| D757H722C40 | K003361 | 000 |
| D757H722C2P1 | K003361 | 000 |
| D757H722A35P1 | K003361 | 000 |
| D757H722A3P1 | K003361 | 000 |
| D757H722B1P1 | K003361 | 000 |
| D757H721C20 | K003361 | 000 |
| D757H721C2P1 | K003361 | 000 |
| D757H721C40 | K003361 | 000 |
| D757H721C4P1 | K003361 | 000 |
| D757H721D30 | K003361 | 000 |
| D757H721D3P1 | K003361 | 000 |
| D757H722B1F0 | K003361 | 000 |