Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K072624 |
Device Name |
ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT |
Applicant |
ASTRA TECH AB |
11234 EL CAMINO REAL, |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
LINDA SCHULZ |
Correspondent |
ASTRA TECH AB |
11234 EL CAMINO REAL, |
SUITE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
LINDA SCHULZ |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 09/17/2007 |
Decision Date | 10/01/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|