The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Ceditec.
Device ID | K220743 |
510k Number | K220743 |
Device Name: | CediTEC |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
Contact | M. Th. Plaumann |
Correspondent | T. Gerkensmeier VOCO GmbH Anton-Flettner-Str. 1-3 Cuxhaven, DE 27472 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-14 |
Decision Date | 2022-07-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
E22160821 | K220743 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CEDITEC 79280479 not registered Live/Pending |
VOCO GmbH 2019-11-29 |