Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K081396 |
Device Name |
SWISSPLANT DENTAL IMPLANT SYSTEM |
Applicant |
IMPLANT DIRECT LLC |
27030 MALIBU HILLS RD. |
CALABASAS HILLS,
CA
91301
|
|
Applicant Contact |
THOMAS GOTTENBOS |
Correspondent |
IMPLANT DIRECT LLC |
27030 MALIBU HILLS RD. |
CALABASAS HILLS,
CA
91301
|
|
Correspondent Contact |
THOMAS GOTTENBOS |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 05/19/2008 |
Decision Date | 01/14/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|