The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Bisco Duo Link D/c Luting Composite.
| Device ID | K934596 |
| 510k Number | K934596 |
| Device Name: | BISCO DUO LINK D/C LUTING COMPOSITE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Contact | Kyong O Joung, Ph.d |
| Correspondent | Kyong O Joung, Ph.d BISCO, INC. 1500 W. THORNDALE AVE. Itasca, IL 60143 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-24 |
| Decision Date | 1994-01-26 |