Device Classification Name |
cord, retraction
|
510(k) Number |
K162662 |
Device Name |
GingiDent Gingival Retraction Paste |
Applicant |
PAC-DENT INTERNATIONAL, INC. |
670 ENDEAVOR CIRCLE |
BREA,
CA
92821
|
|
Applicant Contact |
JIAQING WU |
Correspondent |
PAC-DENT INTERNATIONAL, INC. |
670 Endeavor Circle |
BREA,
CA
92821
|
|
Correspondent Contact |
Jiahe Li |
Classification Product Code |
|
Date Received | 09/26/2016 |
Decision Date | 10/20/2017 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|