The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Tesceraflo A2, Model T-21012p; Tesceraflo A2 Opaque, Model T-210120p.
| Device ID | K030951 |
| 510k Number | K030951 |
| Device Name: | TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P |
| Classification | Material, Tooth Shade, Resin |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Stephen (steve) Smith |
| Correspondent | Stephen (steve) Smith 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 | 2003-03-26 |
| Decision Date | 2003-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757H672B30 | K030951 | 000 |
| D757H664A20 | K030951 | 000 |
| 00810111540193 | K030951 | 000 |
| 00810111540155 | K030951 | 000 |
| 00810111540278 | K030951 | 000 |
| 00810111541909 | K030951 | 000 |
| 00810111540254 | K030951 | 000 |
| 00810111540216 | K030951 | 000 |
| 00810111540131 | K030951 | 000 |
| 00810111540353 | K030951 | 000 |
| 00810111540179 | K030951 | 000 |
| D757H672B10 | K030951 | 000 |
| D757H671A10 | K030951 | 000 |
| D757H675TI0 | K030951 | 000 |
| D757H675OW0 | K030951 | 000 |
| D757H674D30 | K030951 | 000 |
| D757H673C30 | K030951 | 000 |
| D757H673C20 | K030951 | 000 |
| D757H671A50 | K030951 | 000 |
| D757H671A350 | K030951 | 000 |
| D757H671A30 | K030951 | 000 |
| D757H671A2O0 | K030951 | 000 |
| D757H671A20 | K030951 | 000 |
| 00810111540339 | K030951 | 000 |