The following data is part of a premarket notification filed by Cavex Holland B.v. with the FDA for Impressix.
| Device ID | K052455 |
| 510k Number | K052455 |
| Device Name: | IMPRESSIX |
| Classification | Material, Impression |
| Applicant | CAVEX HOLLAND B.V. HARMENJANSWEG 21 Haarlem, NL 2031 Wh |
| Contact | Richard Woortman |
| Correspondent | Richard Woortman CAVEX HOLLAND B.V. HARMENJANSWEG 21 Haarlem, NL 2031 Wh |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-07 |
| Decision Date | 2005-11-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IMPRESSIX 77081391 3441570 Live/Registered |
DENTSPLY SIRONA ORTHODONTICS INC. 2007-01-11 |