Device Classification Name |
cleanser, root canal
|
510(k) Number |
K193357 |
Device Name |
V-Mix |
Applicant |
Inter-Med/ Vista Dental Products |
2220 South Street Suite A |
Racine,
WI
53404
|
|
Applicant Contact |
Katherine Barry |
Correspondent |
Inter-Med/ Vista Dental Products |
2220 South Street Suite A |
Racine,
WI
53404
|
|
Correspondent Contact |
Katherine Barry |
Classification Product Code |
|
Date Received | 12/04/2019 |
Decision Date | 10/23/2020 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|