Device Classification Name |
Agent, Tooth Bonding, Resin
|
510(k) Number |
K974486 |
Device Name |
CLEARFIL LINER BOND 2V |
Applicant |
KURARAY AMERICA, INC. |
200 PARK AVE. |
NEW YORK,
NY
10166 -3098
|
|
Applicant Contact |
KOJI FUJITA |
Correspondent |
KURARAY AMERICA, INC. |
200 PARK AVE. |
NEW YORK,
NY
10166 -3098
|
|
Correspondent Contact |
KOJI FUJITA |
Regulation Number | 872.3200
|
Classification Product Code |
|
Date Received | 11/26/1997 |
Decision Date | 01/29/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|