| Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
| 510(k) Number |
K260555 |
| Device Name |
LOCATOR® Angled Abutment |
| Applicant |
| Zest Anchors, LLC |
| 2875 Loker Ave. E |
|
Carlsbad,
CA
92010
|
|
| Applicant Contact |
DAVID LIN |
| Correspondent |
| Zest Anchors, LLC |
| 2875 Loker Ave. E |
|
Carlsbad,
CA
92010
|
|
| Correspondent Contact |
Maleata Hall |
| Regulation Number | 872.3630 |
| Classification Product Code |
|
| Date Received | 02/18/2026 |
| Decision Date | 04/09/2026 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Special
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|