Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K030689 |
Device Name |
SPI ELEMENT DENTAL IMPLANT O 3.5 MM |
Applicant |
THOMMEN MEDICAL, AG |
11234 EL CAMINO REAL, STE. 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
FLOYD G LARSON |
Correspondent |
THOMMEN MEDICAL, AG |
11234 EL CAMINO REAL, STE. 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
FLOYD G LARSON |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 03/05/2003 |
Decision Date | 03/26/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|