Device Classification Name |
cleanser, root canal
|
510(k) Number |
K211813 |
Device Name |
Triton |
Applicant |
Inter-Med / Vista Dental |
2200 South Street |
Racine,
WI
53404
|
|
Applicant Contact |
Brett Arand |
Correspondent |
Inter-Med / Vista Dental |
2200 South Street |
Racine,
WI
53404
|
|
Correspondent Contact |
Brett Arand |
Classification Product Code |
|
Date Received | 06/11/2021 |
Decision Date | 08/18/2021 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|