Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K060472 |
Device Name |
PREMISE FLOWABLE |
Applicant |
KERR CORPORATION |
100 BAYVIEW CIRCLE STE 6000 |
NEWPORT BEACH,
CA
92660
|
|
Applicant Contact |
COLLEEN BOSWELL |
Correspondent |
KERR CORPORATION |
100 BAYVIEW CIRCLE STE 6000 |
NEWPORT BEACH,
CA
92660
|
|
Correspondent Contact |
COLLEEN BOSWELL |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 02/23/2006 |
Decision Date | 04/28/2006 |
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
|
|
|