The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Colorbite.
| Device ID | K053619 |
| 510k Number | K053619 |
| Device Name: | COLORBITE |
| Classification | Material, Impression |
| Applicant | ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Contact | Gerald W Shipps |
| Correspondent | Gerald W Shipps ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-27 |
| Decision Date | 2006-03-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COLORBITE 78978695 3292378 Live/Registered |
Zhermack S.p.A. 2005-10-27 |
![]() COLORBITE 78741548 not registered Dead/Abandoned |
Zhermack S.p.A. 2005-10-27 |