Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K111958 |
Device Name |
TETRIC EVOCERAM BULK FILL |
Applicant |
IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. |
AMHERST,
NY
14228
|
|
Applicant Contact |
DONNA MARIE HARTNETT |
Correspondent |
IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. |
AMHERST,
NY
14228
|
|
Correspondent Contact |
DONNA MARIE HARTNETT |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 07/11/2011 |
Decision Date | 10/14/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|