Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K223714 |
Device Name |
UniFit Dental Implant System |
Applicant |
Adin Dental Implant Systems Ltd. |
Alon Tavor Industrial Zone P.O.B 1128 |
Afula,
IL
1811101
|
|
Applicant Contact |
Ilana Lutvak |
Correspondent |
Adin Dental Implant Systems Ltd. |
12264 El Camino Real |
Suite 400 |
San Diego,
92130
|
|
Correspondent Contact |
Kevin Thomas |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/12/2022 |
Decision Date | 12/29/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|