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 |