The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for All-bond Universal W/bac (not Finalized).
| Device ID | K161051 |
| 510k Number | K161051 |
| Device Name: | All-Bond Universal W/BAC (not Finalized) |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Bisco, Inc. 1100 West Irving Park Road Schaumburg, IL 60193 |
| Contact | Ryan Hobson |
| Correspondent | Ryan Hobson Bisco, Inc. 1100 West Irving Park Road Schaumburg, IL 60193 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-14 |
| Decision Date | 2016-09-09 |
| Summary: | summary |