510(k) · Cleared
ClearedLOCATOR F-Tx 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 Mar 4, 2016 as substantially equivalent to K072878 (Zest Anchors, Inc., 2007) and 1 other predicate after a 247-day review. Its family tree reaches back 13 generations to 1990. 8 later devices descend from it.
- Decided
- Mar 4, 2016
- Review
- 247 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K894595 (1990). 152 ancestors in all, the oldest K781060 (1978). 8 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 2 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 1 generation backK150295 LOCATOR RTxZest Anchors, Inc. · 2015
- This deviceK151789 LOCATOR F-Tx Attachment SystemZest Anchors, LLC · 2016
- Descendant · cites it directly · 7 of its ownK213391 High Retention Attachment SystemZest Anchors, LLC · 2022
- Descendant · 2 generations on · 4 of its ownK233587 LOCATOR Angled Abutment (Various)Zest Anchors, LLC · 2024
- Descendant · 3 generations on · 3 of its ownK243272 LOCATOR Angled AbutmentZest Anchors, LLC · 2025
- Descendant · 4 generations on · 2 of its ownK250721 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025
- Descendant · 5 generations on · 1 of its ownK252944 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 10 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 9 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 8 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 7 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 6 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 5 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 4 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 3 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 2 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 1 generation backK150295 LOCATOR RTxZest Anchors, Inc. · 2015
- This deviceK151789 LOCATOR F-Tx Attachment SystemZest Anchors, LLC · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K213391High Retention Attachment SystemZest Anchors, LLC · 2022 · cites it directly7descendants
- K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC · 2024 · 2 generations on4descendants
- K243272LOCATOR Angled AbutmentZest Anchors, LLC · 2025 · 3 generations on3descendants
- K250721LOCATOR® Angled AbutmentZest Anchors, LLC · 2025 · 4 generations on2descendants
- K252944LOCATOR® Angled AbutmentZest Anchors, LLC · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −10 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −9 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −8 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −7 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −6 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −5 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −4 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −3 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −2 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −1 | K150295 | LOCATOR RTx | Zest Anchors, Inc. | 2015 | — |
| 0 (this device) | K151789 | LOCATOR F-Tx Attachment System | Zest Anchors, LLC | 2016 | — |
| +1 | K213391 | High Retention Attachment System | Zest Anchors, LLC | 2022 | — |
| +2 | K233587 | LOCATOR Angled Abutment (Various) | Zest Anchors, LLC | 2024 | — |
| +3 | K243272 | LOCATOR Angled Abutment | Zest Anchors, LLC | 2025 | — |
| +4 | K250721 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2025 | — |
| +5 | K252944 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2025 | — |
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 | 2 | 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 30.6 · 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? (2)
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 |
|---|---|---|---|
| * | K072878 | Modification to: Locator Implant AnchorSummary page 4…lassification Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION The primary predicate is K072878. The reference predicate device for the TiCN coating is K150295. The reference predicate devices for the abutment-implant interfa… | 2007 |
| * | K150295 | LOCATOR RTx Cleared while this submission was under review Summary page 4…ng Branch Dental Devices Branch PREDICATE DEVICE INFORMATION The primary predicate is K072878. The reference predicate device for the TiCN coating is K150295. The reference predicate devices for the abutment-implant interface compatibilities are K120414, K071638, K093321, K143022, K0633… | 2015 |
| † | K120414 | Osseospeed Plus | 2012 |
| † | K071638 | Biohorizons Tapered Internal Implant System | 2007 |
| † | K093321 | Biohorizons Laser-Lok 3.0 Implant System | 2010 |
| † | K143022 | BioHorizons Tapered Internal Implants | 2015 |
| † | K063341 | 3I Osseotite Certain Dental Implants | 2007 |
| † | K000100 | Camlog Rootform Implant System | 2000 |
| † | K083496 | Camlog Implant System Modified Implants and Abutments | 2009 |
| † | K113779 | Conelog Implant System | 2012 |
| † | K133991 | ISY | 2014 |
| † | K041509 | Ankylos Dental Implant System | 2004 |
| † | K040807 | Mis Dental Implant System | 2004 |
| † | K071370 | Nobelactive Internal Connection Implant | 2007 |
| † | K102436 | Nobel Active 3.0 | 2010 |
| † | K020646 | Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102… | 2002 |
| † | K022562 | Various Branemark System Implants-Immediate Function Indication | 2002 |
| † | K062129 | P.0004 Implants | 2006 |
| † | K130222 | Straumann Dental Implant System | 2013 |
| † | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… | 2006 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213391 | High Retention Attachment System | 2022 | 7 |
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 26 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 16 of the 152 ancestors have a recall of any class.
- Of its descendants, K213391 (Zest Anchors, LLC, 2022) has gone furthest, with 7 descendants of its own.
- 6 other devices also cite its predicate K072878.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 LOCATOR® F-Tx 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 LOCATOR® F-Tx Attachment System is compatible with the following implants: Implant Manufacturer Connection Type / Platform Astra Tech OsseoSpeed Plus EV: 3.6…
Read the full statement (153 words)
The LOCATOR® F-Tx 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 LOCATOR® F-Tx Attachment System is compatible with the following implants:
Implant Manufacturer Connection Type / Platform
Astra Tech OsseoSpeed Plus EV: 3.6, 4.2, 4.8 mm
BioHorizons Internal Hex: 3.0, 3.5, 4.5, 5.7 mm
Biomet 3i Osseotite® Certain®: 3.4, 4.1, 5.0, 6.0 mm
Camlog Camlog, Conelog: 3.3, 3.8, 4.3, 5.0 mm
iSy: 3.8, 4.4, 5.0 mm
Dentsply Ankylos®: 3.5, 4.5, 5.5, 7.0 mm
MIS Implants Internal Hex: 3.75, 4.5 mm
Nobel Biocare NobelActive™: 3.0, 3.5, 3.9 mm
Replace™ Select: 3.5, 4.3, 5.0, 6.0 mm
Brånemark: 3.5, 4.1, 5.1 mm
Straumann Bone Level: 3.3, 4.1, 4.8 mm
Standard: 4.8, 6.5 mm
Zimmer Tapered Screw-Vent®: 3.5, 4.5, 5.7 mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151789: LOCATOR F-Tx 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/K151789
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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