The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for A-wear.
| Device ID | K012180 |
| 510k Number | K012180 |
| Device Name: | A-WEAR |
| Classification | Material, Tooth Shade, Resin |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Steven J Duray |
| Correspondent | Steven J Duray 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 | 2001-07-12 |
| Decision Date | 2001-09-05 |
| Summary: | summary |