The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Duolink Ii.
| Device ID | K101787 |
| 510k Number | K101787 |
| Device Name: | DUOLINK II |
| Classification | Cement, Dental |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Michelle Schiltz-taing |
| Correspondent | Michelle Schiltz-taing 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 | 2010-06-25 |
| Decision Date | 2010-10-08 |
| Summary: | summary |