The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for One-step Plus.
| Device ID | K011159 |
| 510k Number | K011159 |
| Device Name: | ONE-STEP PLUS |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-11 |
| Decision Date | 2001-06-08 |