Device Classification Name |
Liner, Cavity, Calcium Hydroxide
|
510(k) Number |
K010176 |
Device Name |
CALEX CONDITIONER |
Applicant |
STEPHEN M. KORAL, D.M.D. |
2006 BROADWAY |
BOULDER,
CO
80302
|
|
Applicant Contact |
STEPHEN M KORAL |
Correspondent |
STEPHEN M. KORAL, D.M.D. |
2006 BROADWAY |
BOULDER,
CO
80302
|
|
Correspondent Contact |
STEPHEN M KORAL |
Regulation Number | 872.3250
|
Classification Product Code |
|
Date Received | 01/18/2001 |
Decision Date | 03/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|