# K213391: High Retention Attachment System

- Pathway: 510(k) (Traditional)
- Applicant: Zest Anchors, LLC
- Decided: Jan 11, 2022 after 88 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K894595 (1990). 153 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151789: LOCATOR F-Tx Attachment System, Zest Anchors, LLC (2016) Summary page 5.

## Most influential descendants
- K233587: LOCATOR Angled Abutment (Various) (2024), 4 descendants of its own
- K243272: LOCATOR Angled Abutment (2025), 3 descendants of its own
- K250721: LOCATOR® Angled Abutment (2025), 2 descendants of its own
- K252944: LOCATOR® Angled Abutment (2025), 1 descendant of its own
- K220252: High Retention Attachment System (2022), 1 descendant of its own

## Indications for use
The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. It is used in fixed hybrid restorations that can be attached with a snap-in system. The High Retention Attachment System is compatible with the following implants: Implant Manufacturer — Implant System — Implant Diameter Ace Surgical — Infinity OCTAGON — 3.3, 4.1, 4.8 Ace Surgical — Infinity TRI-CAM — 3.5, 4.3, 5.0 Ace Surgical — Infinity Internal Hex — 3.7, 4.1, 4.7, 5.1 BioHorizons — Tapered Internal — 3.0 BioHorizons — Tapered Plus — 3.8 BioHorizons — Laser-Lok — 3.0 Biomet 3i — 3iT3, NanoTite, OSSEOTITE — 3.25, 3.75, 4.0 Blue Sky Bio — Quattro — 3.3, 4.1, 4.8 Blue Sky Bio — One Stage — 3.3, 4.1, 4.8 Camlog — SCREW-LINE ROOT-LINE 2 — 3.3, 3.8, 4.3, 5.0 Camlog — SCREW-LINE — 3.3, 3.8, 4.3, 5.0 Dentsply — Astra Tech OsseoSpeed EV — 3.6, 4.2, 4.8 Dentsply — Xive Frialit-2 — 3.4, 3.8, 4.5, 5.5 Dentsply — Ankylos C/X — 3.5 Dentsply — Astra Tech OsseoSpeed TX — 3.5, 4.0, 4.5, 5.0 Hiossen, Inc. — SS — 3.5, 4.0, 4.5 Hiossen, Inc. — ET, TS — 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 Hiossen, Inc. — US — 3.5, 3.3, 4.5, 4.0, 5.0, 6.0, 7.0 Implant Direct — Swish Plus — 4.1, 4.8 Implant Direct — SwishTapered — 4.1, 4.8 Implant Direct — InterActive — 3.2, 3.7, 4.3, 5.0 Implant Direct — ReActive — 3.7, 4.2, 4.7, 5.7 Implant Direct — RePlant — 3.5, 4.3, 5.0 Implant Direct — Legacy 1, 2, 3, 4 — 3.7, 4.2 Implant Direct — Legacy 2, 3, 4 — 3.2, 4.7, 5.2 Implant Direct — Legacy 1, 3 — 5.7 Implant Direct — Legacy 2, 4 — 5.7, 7.0 Implant Direct — Legacy 1 — 4.7 IDS — MegaGen Any Ridge — 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 Keystone — PrimaConnex — 3.5, 4.1, 5.0 Keystone — Genesis — 3.5 Keystone — TILOBEMAXX — 7.0, 8.0, 9.0 MIS — C1 — 3.3, 3.75, 4.2 MIS — V3 — 3.3, 3.9, 4.3, 5.0 MIS — SEVEN — 3.3 MIS — M4 — 3.3 Nobel — Replace, Replace Select, NobelSpeedy — 3.5, 4.3, 5.0 Nobel — NobelActive, NobelParallel CC, NobelReplace CC — 3.5, 4.3, 5.5 Nobel — Branemark, Nobel Speedy, Groovy — 3.3, 3.75, 4.0, 5.0 OCO Biomedical — Engage — 3.25, 4.0, 5.0 Southern Implants — Tri-Nex — 3.5, 4.3, 5.0 Southern Implants — Tri-MAX7 — 7.0 Straumann — Roxolid SLActive, Roxolid SLA — 3.3, 4.1, 4.8 Zimmer Dental — Trabecular Metal, Tapered Screw-Vent, Screw-Vent, Advent — 3.7, 4.1, 4.7, 6.0 Zimmer Dental — Spline Reliance Cylinder — 3.25, 4.0, 5.0 Zimmer Dental — Spline Twist — 3.75

Source page: https://510kreport.com/device/K213391
Methodology: https://510kreport.com/methodology