The following data is part of a premarket notification filed by Voco Gmbh with the FDA for V-print Dentbase.
Device ID | K220236 |
510k Number | K220236 |
Device Name: | V-Print Dentbase |
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 | 2022-01-27 |
Decision Date | 2022-09-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
E2216136 | K220236 | 000 |
E22160481 | K220236 | 000 |