Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K160786 |
Device Name |
RODO Abutment System |
Applicant |
RODO MEDICAL, INC |
690 SARATOGA AVE., SUITE 100 |
SAN JOSE,
CA
95129
|
|
Applicant Contact |
Michael Parsons |
Correspondent |
PAXMED INTERNATIONAL, LLC |
12264 EL CAMINO REAL |
SUITE 400 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
Linda K. Schulz |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 03/22/2016 |
Decision Date | 11/21/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02388425
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|