The following data is part of a premarket notification filed by Zhermack Dental Production with the FDA for Thixoflex.
| Device ID | K935896 |
| 510k Number | K935896 |
| Device Name: | THIXOFLEX |
| Classification | Material, Impression |
| Applicant | ZHERMACK DENTAL PRODUCTION VIA BOVAZECCHINO, 100 45021 BADIA POLESINE (rovigo) Italy, IT |
| Contact | Monica Martello |
| Correspondent | Monica Martello ZHERMACK DENTAL PRODUCTION VIA BOVAZECCHINO, 100 45021 BADIA POLESINE (rovigo) Italy, IT |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1994-09-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THIXOFLEX 86273377 4674532 Live/Registered |
Aviation Devices & Electronic Components, LLC 2014-05-06 |
![]() THIXOFLEX 75615636 not registered Dead/Abandoned |
Zhermack S.p.A. 1999-01-05 |