Device Classification Name |
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
|
510(k) Number |
K073209 |
Device Name |
MAXCEM 2 |
Applicant |
KERR CORPORATION |
1717 WEST COLLINS AVE. |
ORANGE,
CA
92867
|
|
Applicant Contact |
COLLEEN BOSWELL |
Correspondent |
KERR CORPORATION |
1717 WEST COLLINS AVE. |
ORANGE,
CA
92867
|
|
Correspondent Contact |
COLLEEN BOSWELL |
Regulation Number | 872.3275
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/14/2007 |
Decision Date | 01/29/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|