| Device Classification Name |
Implant, Endosseous, Root-Form
|
| 510(k) Number |
K902331 |
| Device Name |
BUD DENTAL IMPLANT SYSTEM |
| Applicant |
| Bud Industries, Inc. |
| P.O. Box 1 |
| 2 N. Main St. |
|
Holland,
NY
14080
|
|
| Applicant Contact |
ROBERT E DUTHIE |
| Correspondent |
| Bud Industries, Inc. |
| P.O. Box 1 |
| 2 N. Main St. |
|
Holland,
NY
14080
|
|
| Correspondent Contact |
ROBERT E DUTHIE |
| Regulation Number | 872.3640 |
| Classification Product Code |
|
| Date Received | 05/24/1990 |
| Decision Date | 07/05/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|