Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K141450 |
Device Name |
AXIOM 2.8 |
Applicant |
ANTHOGYR SAS |
2237, AVENUE ANDRE LASQUIN |
SALLANCHES,
FR
74700
|
|
Applicant Contact |
THERESE CANDAU |
Correspondent |
ANTHOGYR SAS |
2237, AVENUE ANDRE LASQUIN |
SALLANCHES,
FR
74700
|
|
Correspondent Contact |
THERESE CANDAU |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/02/2014 |
Decision Date | 09/17/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|