| Device Classification Name |
Implant, Endosseous, Root-Form
|
| 510(k) Number |
K001259 |
| Device Name |
2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM |
| Applicant |
| Basic Dental Implant Systems, Inc. |
| 3321 Columbia NE |
|
Albuquerque,
NM
87107 -2001
|
|
| Applicant Contact |
DAN BLACKLOCK |
| Correspondent |
| Basic Dental Implant Systems, Inc. |
| 3321 Columbia NE |
|
Albuquerque,
NM
87107 -2001
|
|
| Correspondent Contact |
DAN BLACKLOCK |
| Regulation Number | 872.3640 |
| Classification Product Code |
|
| Date Received | 04/19/2000 |
| Decision Date | 01/12/2001 |
| 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
|
|
|