Device Classification Name |
Alloy, Gold-Based Noble Metal
|
510(k) Number |
K032106 |
Device Name |
STARBOND DENTAL BONDING ALLOYS |
Applicant |
STAR REFINING PRECIOUS METALS SOUTH AFRICA |
PO BOX 4341 |
CROFTON,
MD
21114
|
|
Applicant Contact |
YOLANDA SMITH |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
NED E DEVINE |
Regulation Number | 872.3060
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/08/2003 |
Decision Date | 08/25/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|