Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K051527 |
Device Name |
SPI EASY TEMPORARY CAP |
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 | 872.3630 |
Classification Product Code |
|
Date Received | 06/08/2005 |
Decision Date | 07/28/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|