Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K142211 |
Device Name |
OT EQUATOR |
Applicant |
Rhein '83 SRL |
Via Emilio Zago, 10/abc |
Bologna,
IT
40128
|
|
Applicant Contact |
Claudia Nardi |
Correspondent |
Rhein '83 SRL |
Via Emilio Zago, 10/abc |
Bologna,
IT
40128
|
|
Correspondent Contact |
Claudia Nardi |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 08/12/2014 |
Decision Date | 11/25/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|