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 Apr 14, 2022 as substantially equivalent to K213391 (Zest Anchors, LLC, 2022) after a 73-day review. Its family tree reaches back 15 generations to 1990. 1 later device descends from it.
- Decided
- Apr 14, 2022
- Review
- 73 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K894595 (1990). 154 ancestors in all, the oldest K781060 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations between
- 3 generations backK150295 LOCATOR RTxZest Anchors, Inc. · 2015
- 2 generations backK151789 LOCATOR F-Tx Attachment SystemZest Anchors, LLC · 2016
- 1 generation backK213391 High Retention Attachment SystemZest Anchors, LLC · 2022
- This deviceK220252 High Retention Attachment SystemZest Anchors, LLC · 2022
- Descendant · cites it directly · 0 of its ownK231132 J & P Click AttachmentsJ & P Dental Technologies · 2024
Show all 15 generations
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 14 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 13 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 12 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 11 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 10 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 9 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 8 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 7 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 6 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 5 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 4 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 3 generations backK150295 LOCATOR RTxZest Anchors, Inc. · 2015
- 2 generations backK151789 LOCATOR F-Tx Attachment SystemZest Anchors, LLC · 2016
- 1 generation backK213391 High Retention Attachment SystemZest Anchors, LLC · 2022
- This deviceK220252 High Retention Attachment SystemZest Anchors, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K231132J & P Click AttachmentsJ & P Dental Technologies · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −14 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −13 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −12 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −11 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −10 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −9 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −8 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −7 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −6 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −5 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −4 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −3 | K150295 | LOCATOR RTx | Zest Anchors, Inc. | 2015 | — |
| −2 | K151789 | LOCATOR F-Tx Attachment System | Zest Anchors, LLC | 2016 | — |
| −1 | K213391 | High Retention Attachment System | Zest Anchors, LLC | 2022 | — |
| 0 (this device) | K220252 | High Retention Attachment System | Zest Anchors, LLC | 2022 | — |
| +1 | K231132 | J & P Click Attachments | J & P Dental Technologies | 2024 | — |
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 |
|---|---|---|
| 2024 | 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 30.6 · 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 |
|---|---|---|---|
| * | K213391 | High Retention Attachment SystemSummary page 5…Predicate Device Predicate Device 510(k) Number High Retention Attachment System: Zest Anchors, LLC K213391 Reference Devices 510(k) Number Locator Overdenture Implant System, Zest Anchor… | 2022 |
| † | K120198 | Locator Overdenture Implant System | 2012 |
| † | K203701 | Locator Overdenture Implant System | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231132 | J & P Click Attachments | 2024 | 0 |
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 1.1 years on median.
- 16 of the 154 ancestors have a recall of any class.
- Of its descendants, K231132 (J & P Dental Technologies, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K213391.
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 OCTAGON…
Read the full statement (339 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
Infinity TRI-CAM 3.5, 4.3, 5.0
Infinity Internal Hex 3.7, 4.1, 4.7, 5.1
BioHorizons Tapered Internal 3.0
Tapered Plus 3.8
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
One Stage 3.3, 4.1, 4.8
Camlog SCREW-LINE ROOT-LINE 2 3.3, 3.8, 4.3, 5.0
SCREW-LINE 3.3, 3.8, 4.3, 5.0
Dentsply Astra Tech OsseoSpeed EV 3.6, 4.2, 4.8
Xive Frialit-2 3.4, 3.8, 4.5, 5.5
Ankylos C/X 3.5
Astra Tech OsseoSpeed TX 3.5, 4.0, 4.5, 5.0
Hiossen, Inc. SS 3.5, 4.0, 4.5
ET, TS 3.5, 4.0, 4.5, 5.0, 6.0, 7.0
US 3.5, 3.3, 4.5, 4.0, 5.0, 6.0, 7.0
Implant Direct Swish Plus 4.1, 4.8
SwishTapered 4.1, 4.8
InterActive 3.2, 3.7, 4.3, 5.0
ReActive 3.7, 4.2, 4.7, 5.7
RePlant 3.5, 4.3, 5.0
Legacy 1, 2, 3, 4 3.7, 4.2
Legacy 2, 3, 4 3.2, 4.7, 5.2
Legacy 1, 3 5.7
Legacy 2, 4 5.7, 7.0
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
Genesis 3.5
TILOBEMAXX 7.0, 8.0, 9.0
MIS C1 3.3, 3.75, 4.2
V3 3.3, 3.9, 4.3, 5.0
SEVEN 3.3
M4 3.3
Nobel Replace, Replace Select, NobelSpeedy 3.5, 4.3, 5.0
NobelActive, NobelParallel CC, NobelReplace CC 3.5, 4.3, 5.5
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
Tri-MAX7 7.0
Straumann Roxolid SLActive, Roxolid SLA 3.3, 4.1, 4.8
Zest Dental Solutions Locator Overdenture Implant System 2.4, 2.9, 3.5, 3.9, 4.4, 4.9
Zimmer Dental Trabecular Metal, Tapered Screw-Vent, Screw-Vent, 3.7, 4.1, 4.7, 6.0
Advent
Spline Reliance Cylinder 3.25, 4.0, 5.0
Spline Twist 3.75
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220252 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220252: High Retention Attachment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220252
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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