The following data is part of a premarket notification filed by Scican with the FDA for Tcb Temporary Crown And Bridge Material.
| Device ID | K964691 |
| 510k Number | K964691 |
| Device Name: | TCB TEMPORARY CROWN AND BRIDGE MATERIAL |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | SCICAN 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Contact | Eva Young |
| Correspondent | Eva Young SCICAN 1440 DON MILLS RD. Toronto, Ontario, CA M3b 3p9 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-22 |
| Decision Date | 1997-02-04 |