Device Classification Name |
Agent, Tooth Bonding, Resin
|
510(k) Number |
K973245 |
Device Name |
TOKUSO REBASE MR. BOND |
Applicant |
TOKUYAMA AMERICA, INC. |
1233 20TH., N.W. #700 |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
DANIEL J MANELLI |
Correspondent |
TOKUYAMA AMERICA, INC. |
1233 20TH., N.W. #700 |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
DANIEL J MANELLI |
Regulation Number | 872.3200
|
Classification Product Code |
|
Date Received | 08/29/1997 |
Decision Date | 10/07/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|