510(k) · Cleared
ClearedLOCATOR® Angled Abutment
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 9, 2026 as substantially equivalent to K252944 (Zest Anchors, LLC, 2025) after a 50-day review. Its family tree reaches back 19 generations to 1990.
- Decided
- Apr 9, 2026
- Review
- 50 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K894595 (1990). 158 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 19 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 15 generations between
- 3 generations backK243272 LOCATOR Angled AbutmentZest Anchors, LLC · 2025
- 2 generations backK250721 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025
- 1 generation backK252944 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025
- This deviceK260555 LOCATOR® Angled AbutmentZest Anchors, LLC · 2026
Show all 19 generations
- Root · 19 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 18 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 17 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 16 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 15 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 14 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 13 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 12 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 11 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 10 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 9 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 8 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
- 7 generations backK150295 LOCATOR RTxZest Anchors, Inc. · 2015
- 6 generations backK151789 LOCATOR F-Tx Attachment SystemZest Anchors, LLC · 2016
- 5 generations backK213391 High Retention Attachment SystemZest Anchors, LLC · 2022
- 4 generations backK233587 LOCATOR Angled Abutment (Various)Zest Anchors, LLC · 2024
- 3 generations backK243272 LOCATOR Angled AbutmentZest Anchors, LLC · 2025
- 2 generations backK250721 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025
- 1 generation backK252944 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025
- This deviceK260555 LOCATOR® Angled AbutmentZest Anchors, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −18 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −17 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −16 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −15 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −14 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −13 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −12 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −11 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −10 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −9 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −8 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| −7 | K150295 | LOCATOR RTx | Zest Anchors, Inc. | 2015 | — |
| −6 | K151789 | LOCATOR F-Tx Attachment System | Zest Anchors, LLC | 2016 | — |
| −5 | K213391 | High Retention Attachment System | Zest Anchors, LLC | 2022 | — |
| −4 | K233587 | LOCATOR Angled Abutment (Various) | Zest Anchors, LLC | 2024 | — |
| −3 | K243272 | LOCATOR Angled Abutment | Zest Anchors, LLC | 2025 | — |
| −2 | K250721 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2025 | — |
| −1 | K252944 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2025 | — |
| 0 (this device) | K260555 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K252944 | LOCATOR® Angled AbutmentSummary page 7…510(k) Number LOCATOR Angled Abutment: Zest Anchors, LLC K252944 Reference Devices 510(k) Number EK Digital Abutments… | 2025 |
| † | K233389 | EK Digital Abutments | 2024 |
| † | K170421 | ET Hybrid Abutment | 2018 |
| † | K222636 | ET Abutment System | 2023 |
| † | K203360 | EK Implants and Abutments System | 2022 |
| † | K240232 | EK D3.3 and Ultra Wide Implants | 2024 |
| † | K120847 | ET/SS Implant System | 2012 |
| † | K103537 | ET Iii SA Ultra Wide System | 2011 |
| † | K153332 | ETIII SA Fixture System (O3.2mm) | 2016 |
| † | K183242 | ET IV SA Dental Implants | 2019 |
| † | K140934 | Hiossen Implant System | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 36 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 16 of the 158 ancestors have a recall of any class.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Angled Abutment is indicated for the attachment of full or partial, fixed and removable,
restorations retained by endosseous implants to restore masticatory function for the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260555: LOCATOR® Angled Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260555
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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