Device Classification Name |
Varnish, Cavity
|
510(k) Number |
K003482 |
Device Name |
PROCLUDE-SENSITIVE |
Applicant |
ORTEK THERAPEUTICS, INC. |
305 MADISON AVE. |
SUITE 2501 |
NEW YORK,
NY
10165
|
|
Applicant Contact |
JULES T MITCHEL |
Correspondent |
ORTEK THERAPEUTICS, INC. |
305 MADISON AVE. |
SUITE 2501 |
NEW YORK,
NY
10165
|
|
Correspondent Contact |
JULES T MITCHEL |
Regulation Number | 872.3260
|
Classification Product Code |
|
Date Received | 11/09/2000 |
Decision Date | 02/01/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|