Device Classification Name |
Alloy, Gold-Based Noble Metal
|
510(k) Number |
K030436 |
Device Name |
BIO UNIVERSAL |
Applicant |
IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. |
AMHERST,
NY
14228
|
|
Applicant Contact |
ANDERJEET GULATI |
Correspondent |
IVOCLAR VIVADENT, INC. |
175 PINEVIEW DR. |
AMHERST,
NY
14228
|
|
Correspondent Contact |
ANDERJEET GULATI |
Regulation Number | 872.3060
|
Classification Product Code |
|
Date Received | 02/10/2003 |
Decision Date | 04/15/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|