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510(k) K151789

LOCATOR F-Tx Attachment System by Zest Anchors, LLC — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2016
Date Received
July 1, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other clearances by Zest Anchors, LLC

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  • K233587 — LOCATOR Angled Abutment (Various) (June 3, 2024)
  • K220252 — High Retention Attachment System (April 14, 2022)
  • K213391 — High Retention Attachment System (January 11, 2022)
  • K191619 — TurboTemp EZ (September 11, 2019)
  • K150295 — LOCATOR RTx (July 24, 2015)
  • K133327 — SATURNO(TM) OVERDENTURE IMPLANT SYSTEM (June 25, 2014)
  • K140570 — CHAIRSIDE ATTACHMENT PROCESSING MATERIAL (June 16, 2014)

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