Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K071638 |
Device Name |
BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM |
Applicant |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
11234 EL CAMINO REAL, STE. 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
LINDA K SCHULZ |
Correspondent |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
11234 EL CAMINO REAL, STE. 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
LINDA K SCHULZ |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/15/2007 |
Decision Date | 10/10/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|