Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K160382 |
Device Name |
OT EQUATOR |
Applicant |
RHEIN'83 SRL |
VIA E. ZAGO 10/ABC |
BOLOGNA,
IT
40128
|
|
Applicant Contact |
CLAUDIA NARDI |
Correspondent |
RHEIN'83 SRL |
VIA E. ZAGO 10/ABC |
BOLOGNA,
IT
40128
|
|
Correspondent Contact |
CLAUDIA NARDI |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 02/10/2016 |
Decision Date | 08/11/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|