| Device Classification Name |
Implant, Endosseous, Root-Form
|
| 510(k) Number |
K820163 |
| Device Name |
ENDOSSEOUS SCREW IMPLANT |
| Applicant |
| General A. Nitznick, D.M.D. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| General A. Nitznick, D.M.D. |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Regulation Number | 872.3640 |
| Classification Product Code |
|
| Date Received | 01/20/1982 |
| Decision Date | 03/11/1982 |
| 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
|
|
|