Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K162257 |
Device Name |
P1145 Dental Restorative |
Applicant |
Kerr Corporation |
1717 W. Collins Ave |
Orange,
CA
92867
|
|
Applicant Contact |
Mohammad Saad Ansari |
Correspondent |
Sybron Dental Specialties |
1717 W. Collins Ave |
Orange,
CA
92867
|
|
Correspondent Contact |
Mohammad Saad Ansari |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 08/11/2016 |
Decision Date | 11/07/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|