510(k) · Cleared
ClearedHigh Retention Attachment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zest Anchors, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jan 11, 2022 as substantially equivalent to K151789 (Zest Anchors, LLC, 2016) after an 88-day review. Its family tree reaches back 14 generations to 1990. 7 later devices descend from it.
- Decided
- Jan 11, 2022
- Review
- 88 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K894595 (1990). 153 ancestors in all, the oldest K781060 (1978). 7 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations between
- 3 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 2 generations backK150295 LOCATOR RTxZest Anchors, Inc. · 2015
- 1 generation backK151789 LOCATOR F-Tx Attachment SystemZest Anchors, LLC · 2016
- This deviceK213391 High Retention Attachment SystemZest Anchors, LLC · 2022
- Descendant · cites it directly · 4 of its ownK233587 LOCATOR Angled Abutment (Various)Zest Anchors, LLC · 2024
- Descendant · 2 generations on · 3 of its ownK243272 LOCATOR Angled AbutmentZest Anchors, LLC · 2025
- Descendant · 3 generations on · 2 of its ownK250721 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025
- Descendant · 4 generations on · 1 of its ownK252944 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025
- Descendant · cites it directly · 1 of its ownK220252 High Retention Attachment SystemZest Anchors, LLC · 2022
Show all 14 generations
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 12 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 11 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 10 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 9 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 8 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 7 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 6 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 5 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 4 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 3 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 2 generations backK150295 LOCATOR RTxZest Anchors, Inc. · 2015
- 1 generation backK151789 LOCATOR F-Tx Attachment SystemZest Anchors, LLC · 2016
- This deviceK213391 High Retention Attachment SystemZest Anchors, LLC · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC · 2024 · cites it directly4descendants
- K243272LOCATOR Angled AbutmentZest Anchors, LLC · 2025 · 2 generations on3descendants
- K250721LOCATOR® Angled AbutmentZest Anchors, LLC · 2025 · 3 generations on2descendants
- K252944LOCATOR® Angled AbutmentZest Anchors, LLC · 2025 · 4 generations on1descendant
- K220252High Retention Attachment SystemZest Anchors, LLC · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −13 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −12 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −11 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −10 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −9 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −8 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −7 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −6 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −5 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −4 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −3 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −2 | K150295 | LOCATOR RTx | Zest Anchors, Inc. | 2015 | — |
| −1 | K151789 | LOCATOR F-Tx Attachment System | Zest Anchors, LLC | 2016 | — |
| 0 (this device) | K213391 | High Retention Attachment System | Zest Anchors, LLC | 2022 | — |
| +1 | K233587 | LOCATOR Angled Abutment (Various) | Zest Anchors, LLC | 2024 | — |
| +2 | K243272 | LOCATOR Angled Abutment | Zest Anchors, LLC | 2025 | — |
| +3 | K250721 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2025 | — |
| +4 | K252944 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2025 | — |
| +1 | K220252 | High Retention Attachment System | Zest Anchors, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 11 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.7 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151789 | LOCATOR F-Tx Attachment SystemSummary page 5…Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1) Dental Devices (DHT1B) PREDICATE DEVICE INFORMATION Primary Predicate Device K151789, LOCATOR F-Tx Attachment System, Zest Anchors, LLC Reference Devices K072878, LOCATOR Implant Anchor Abutment, Zest Anchors, LLC… | 2016 |
| † | K072878 | Modification to: Locator Implant Anchor | 2007 |
| † | K200827 | LOCATOR R-Tx | 2020 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 16 of the 153 ancestors have a recall of any class.
- Of its descendants, K233587 (Zest Anchors, LLC, 2024) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
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…
Read the full statement (468 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213391: High Retention Attachment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213391
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026