The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Ace Bond Se.
| Device ID | K063780 |
| 510k Number | K063780 |
| Device Name: | ACE BOND SE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Benjamin Lichtenwalner |
| Correspondent | Benjamin Lichtenwalner BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-21 |
| Decision Date | 2007-01-19 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ACE BOND SE 78866141 not registered Dead/Abandoned |
Bisco, Inc. 2006-04-20 |