Device Classification Name |
Agent, Tooth Bonding, Resin
|
510(k) Number |
K912707 |
Device Name |
CLEARFIL LINER BOND SYSTEM |
Applicant |
KURARAY CO. |
200 PARK AVE. |
NEW YORK,
NY
10166
|
|
Applicant Contact |
TOHRU SHIMIZU |
Correspondent |
KURARAY CO. |
200 PARK AVE. |
NEW YORK,
NY
10166
|
|
Correspondent Contact |
TOHRU SHIMIZU |
Regulation Number | 872.3200
|
Classification Product Code |
|
Date Received | 06/19/1991 |
Decision Date | 08/20/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|