| Device Classification Name |
Implant, Endosseous, Root-Form
|
| 510(k) Number |
K922872 |
| Device Name |
INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM. |
| Applicant |
| Interpore Intl. |
| 18008 Skypark Cir. |
|
Irvine,
CA
92714
|
|
| Applicant Contact |
WILLIAM A FRANKLIN |
| Correspondent |
| Interpore Intl. |
| 18008 Skypark Cir. |
|
Irvine,
CA
92714
|
|
| Correspondent Contact |
WILLIAM A FRANKLIN |
| Regulation Number | 872.3640 |
| Classification Product Code |
|
| Date Received | 06/15/1992 |
| Decision Date | 07/25/1994 |
| 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
|
|
|