Device Classification Name |
Agent, Tooth Bonding, Resin
|
510(k) Number |
K010415 |
Device Name |
ISODAN |
Applicant |
SPECIALITES SEPTODONT |
1050 CONNECTICUT AVE. NW |
WASHINGTON,
DC
20036 -5339
|
|
Applicant Contact |
PETER S REICHERZ |
Correspondent |
SPECIALITES SEPTODONT |
1050 CONNECTICUT AVE. NW |
WASHINGTON,
DC
20036 -5339
|
|
Correspondent Contact |
PETER S REICHERZ |
Regulation Number | 872.3200
|
Classification Product Code |
|
Date Received | 02/12/2001 |
Decision Date | 07/23/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|