Device Classification Name |
Cord, Retraction
|
510(k) Number |
K162948 |
Device Name |
Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials |
Applicant |
KERR CORPORATION |
1717 W. COLLINS AVE. |
ORANGE,
CA
92867
|
|
Applicant Contact |
Jennifer Dzidrums |
Correspondent |
SYBRON DENTAL SPECIALTIES |
1717 W. COLLINS AVE. |
ORANGE,
CA
92867
|
|
Correspondent Contact |
Mohammad Saad Ansari |
Classification Product Code |
|
Date Received | 10/21/2016 |
Decision Date | 08/08/2017 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|