Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K181381 |
Device Name |
A.B. Dental Devices Dental Implants System |
Applicant |
A.B Dental Device Ltd. |
19 Hayalomim St. |
Ashdod,
IL
7761117
|
|
Applicant Contact |
Gabi Krauss |
Correspondent |
Hogan Lovells US LLP |
555 13th St. NW |
Washington,
DC
20004
|
|
Correspondent Contact |
John J. Smith |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 05/24/2018 |
Decision Date | 11/23/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|