Device Classification Name |
cleanser, root canal
|
510(k) Number |
K200330 |
Device Name |
RC-Prime Root Canal Preparation Cream |
Applicant |
Pac-Dent, Inc |
670 Endeavor Circle |
Brea,
CA
92821
|
|
Applicant Contact |
Daniel Wang |
Correspondent |
Pac-Dent, Inc |
670 Endeavor Circle |
Brea,
CA
92821
|
|
Correspondent Contact |
Daisy Ni |
Classification Product Code |
|
Date Received | 02/10/2020 |
Decision Date | 07/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|