| Device Classification Name |
Implant, Endosseous, Root-Form
|
| 510(k) Number |
K873437 |
| Device Name |
BIONIC-TOOTH-PLANT MODEL A-1 |
| Applicant |
| Larry R. Ashkinazy, D.D.S. |
| 200 Central Park S. |
|
New York,
NY
10019
|
|
| Correspondent |
| Larry R. Ashkinazy, D.D.S. |
| 200 Central Park S. |
|
New York,
NY
10019
|
|
| Regulation Number | 872.3640 |
| Classification Product Code |
|
| Date Received | 08/27/1987 |
| Decision Date | 06/13/1988 |
| 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
|
|
|