Device Classification Name |
saliva, artificial
|
510(k) Number |
K203567 |
Device Name |
Oral-B Dry Mouth Oral Rinse |
Applicant |
The Procter & Gamble Company |
1 Procter & Gamble Plaza |
Cincinnati,
OH
45202
|
|
Applicant Contact |
Brenda S. Fuentes |
Correspondent |
The Procter & Gamble Company |
1 Procter & Gamble Plaza |
Cincinnati,
OH
45202
|
|
Correspondent Contact |
Brenda S. Fuentes |
Classification Product Code |
|
Date Received | 12/07/2020 |
Decision Date | 04/05/2021 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT04189081
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|