Device Classification Name |
Diammine Silver Fluoride Dental Hypersensitivity Varnish
|
510(k) Number |
K240059 |
Device Name |
FAgamin® |
Applicant |
Tedequim SRL |
Bv. Los Polacos 6136. |
Córdoba,
AR
X5147GGP
|
|
Applicant Contact |
Leonor Pasteris |
Correspondent |
Compliance 4 Devices |
118 W Prive Cr. |
Delray Beach,
FL
33445
|
|
Correspondent Contact |
Juan Tezak |
Regulation Number | 872.3260
|
Classification Product Code |
|
Date Received | 01/08/2024 |
Decision Date | 05/16/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|