| Device Classification Name |
Implant, Endosseous, Root-Form
|
| 510(k) Number |
K914043 |
| Device Name |
MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA |
| Applicant |
| Midwest Implant Sales, Inc. |
| P.O. Box 681038 |
|
Schaumburg,
IL
60168
|
|
| Applicant Contact |
JOHN T CORSTEN |
| Correspondent |
| Midwest Implant Sales, Inc. |
| P.O. Box 681038 |
|
Schaumburg,
IL
60168
|
|
| Correspondent Contact |
JOHN T CORSTEN |
| Regulation Number | 872.3640 |
| Classification Product Code |
|
| Date Received | 09/10/1991 |
| Decision Date | 12/09/1991 |
| 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
|
|
|