Device Classification Name |
cord, retraction
|
510(k) Number |
K213149 |
Device Name |
VOCO Retraction Paste |
Applicant |
Voco GmbH |
Anton-Flettner-Str. 1-3 |
Cuxhaven,
DE
27472
|
|
Applicant Contact |
M Th Plaumann |
Correspondent |
Voco GmbH |
Anton-Flettner-Str. 1-3 |
Cuxhaven,
DE
27472
|
|
Correspondent Contact |
T Gerkensmeier |
Classification Product Code |
|
Date Received | 09/27/2021 |
Decision Date | 12/09/2021 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|