Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K193274 |
Device Name |
Rodo Abutment System |
Applicant |
RODO Medical, Inc. |
6399 San Ignacio Ave., Suite 100 |
San Jose,
CA
95119
|
|
Applicant Contact |
James Park |
Correspondent |
Hogan Lovells US LLP |
555 13th St. NW |
Washington,
DC
20004
|
|
Correspondent Contact |
Randy Prebula |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 11/26/2019 |
Decision Date | 02/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|