Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K061807 |
Device Name |
SPI ART ABUTMENTS |
Applicant |
THOMMEN MEDICAL, AG |
11234 EL CAMINO REAL, STE. 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
Floyd Larson |
Correspondent |
THOMMEN MEDICAL, AG |
11234 EL CAMINO REAL, STE. 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
Floyd Larson |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 06/27/2006 |
Decision Date | 07/31/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|