The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Colorise.
| Device ID | K070677 |
| 510k Number | K070677 |
| Device Name: | COLORISE |
| 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 | 2007-03-12 |
| Decision Date | 2007-05-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COLORISE 97884771 not registered Live/Pending |
Dentsply Sirona Inc. 2023-04-12 |
![]() COLORISE 79032607 3572713 Dead/Cancelled |
ZHERMACK S.P.A. 2006-10-03 |