Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K133991 |
Device Name |
ISY |
Applicant |
ALTATEC GMBH |
12264 EL CAMINO REAL |
SUITE 400 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
LINDA SCHULZ |
Correspondent |
ALTATEC GMBH |
12264 EL CAMINO REAL |
SUITE 400 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
LINDA SCHULZ |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/26/2013 |
Decision Date | 08/06/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|