Device Classification Name |
abutment, implant, dental, endosseous
|
510(k) Number |
K213391 |
Device Name |
High Retention Attachment System |
Applicant |
Zest Anchors, LLC |
2875 Loker Avenue East |
Carlsbad,
CA
92010
|
|
Applicant Contact |
Mark Stavro |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Melissa Burbage |
Regulation Number | 872.3630
|
Classification Product Code |
|
Date Received | 10/15/2021 |
Decision Date | 01/11/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|