Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K053384 |
Device Name |
FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM |
Applicant |
ASTRA TECH, INC. |
11234 EL CAMINO REAL, STE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
FLOYD G LARSON |
Correspondent |
ASTRA TECH, INC. |
11234 EL CAMINO REAL, STE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
FLOYD G LARSON |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 12/05/2005 |
Decision Date | 03/24/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|