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 |