Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K181359 |
Device Name |
InterActive SMARTBase Abutments |
Applicant |
Implant Direct Sybron Manufacturing LLC |
3050 East Hillcrest Drive |
Thousand Oaks,
CA
91362
|
|
Applicant Contact |
Reina Choi |
Correspondent |
Implant Direct Sybron Manufacturing LLC |
3050 East Hillcrest Drive |
Thousand Oaks,
CA
91362
|
|
Correspondent Contact |
Reina Choi |
Regulation Number | 872.3630
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/22/2018 |
Decision Date | 08/15/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|