510(k) Report

510(k) · Cleared

Cleared

LOCATOR Angled Abutment (Various)

K233587510(k) TraditionalCleared Jun 3, 2024208-day reviewClass II21 CFR 872.3630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Zest Anchors, LLC · NHA Abutment, Implant, Dental, Endosseous

Cleared on Jun 3, 2024 as substantially equivalent to K213391 (Zest Anchors, LLC, 2022) after a 208-day review. Its family tree reaches back 15 generations to 1990. 4 later devices descend from it.

Decided
Jun 3, 2024
Review
208 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). 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 6 other ancestors2012: 1 other ancestor2011: 3 other ancestors2010: 5 other ancestors2009: 3 other ancestors2008: 4 other ancestors1998: 7 other ancestors1994: 10 other ancestors2006: 1 other ancestor2005: 4 other ancestors2004: 5 other ancestors2003: 7 other ancestors2002: 11 other ancestors1999: 7 other ancestors1997: 6 other ancestors1995: 10 other ancestors1988: 1 other ancestor2001: 3 other ancestors2000: 3 other ancestors1996: 11 other ancestors1993: 11 other ancestors1990: 5 other ancestors1989: 5 other ancestors1987: 2 other ancestors1986: 2 other ancestors1992: 2 other ancestors1985: 1 other ancestor1982: 1 other ancestor1978: 1 other ancestor1991: 1 other ancestor2025: 3 descendants cleared2026: 1 descendant clearedReference device: K190040 · Straumann BLX Line Extension - New Abutments · Institut Straumann AG · 2019Reference device: K072878 · Modification to: Locator Implant Anchor · Zest Anchors, Inc. · 2007 · recalledReference device: K173961 · Straumann BLX Implant System · Institut Straumann AG · 2018Reference device: K181703 · Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments · Institut Straumann AG · 2018Reference device: K210855 · Straumann BLX Implant System · Institut Straumann AG · 2021Reference device: K212533 · BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants · Institut Straumann AG · 2022K894595 · Bonefit R Screw Implants · Institut Straumann AG · 1990K984104 · Iti Dental Implant System · Straumann USA · 1999 · recalledK993595 · Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement) · Nobel Biocare Uas, Inc. · 2000K023113 · Replace Tiunite Endosseous Implant · Nobel Biocare Uas, Inc. · 2002 · recalledK041661 · Nobel Biocare Endosseous Implants · Nobel Biocare Uas, Inc. · 2004K050258 · Groovy Implants · Nobel Biocare AB · 2005 · recalledK061003 · SFB & CFB Implants · Nobel Biocare AB · 2006K071370 · Nobelactive Internal Connection Implant · Nobel Biocare AB · 2007 · recalledK101732 · Astra Tech Implant System · Astra Tech AB · 2011×2: 2 generations cleared close together, K111287 (2011), K112138 (2011) K120414 · Osseospeed Plus · Astra Tech AB · 2012K150295 · LOCATOR RTx · Zest Anchors, Inc. · 2015K151789 · LOCATOR F-Tx Attachment System · Zest Anchors, LLC · 2016K213391 · High Retention Attachment System · Zest Anchors, LLC · 202219801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor5 generations back: 15 other ancestors6 generations back: 20 other ancestors7 generations back: 18 other ancestors8 generations back: 26 other ancestors9 generations back: 29 other ancestors10 generations back: 7 other ancestors11 generations back: 3 other ancestors12 generations back: 11 other ancestors13 generations back: 8 other ancestors14 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant K213391 · High Retention Attachment System · Zest Anchors, LLC · 2022K151789 · LOCATOR F-Tx Attachment System · Zest Anchors, LLC · 2016K150295 · LOCATOR RTx · Zest Anchors, Inc. · 2015K120414 · Osseospeed Plus · Astra Tech AB · 2012K112138 · Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant · Astra Tech, Inc. · 2011K111287 · Astra Tech Implant System · Astra Tech AB · 2011K101732 · Astra Tech Implant System · Astra Tech AB · 2011K071370 · Nobelactive Internal Connection Implant · Nobel Biocare AB · 2007 · recalledK061003 · SFB & CFB Implants · Nobel Biocare AB · 2006K050258 · Groovy Implants · Nobel Biocare AB · 2005 · recalledK041661 · Nobel Biocare Endosseous Implants · Nobel Biocare Uas, Inc. · 2004K023113 · Replace Tiunite Endosseous Implant · Nobel Biocare Uas, Inc. · 2002 · recalledK993595 · Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement) · Nobel Biocare Uas, Inc. · 2000K984104 · Iti Dental Implant System · Straumann USA · 1999 · recalledK894595 · Bonefit R Screw Implants · Institut Straumann AG · 1990−15−10−50
  1. Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
  2. 11 generations between
  3. 3 generations backK150295 LOCATOR RTxZest Anchors, Inc. · 2015
  4. 2 generations backK151789 LOCATOR F-Tx Attachment SystemZest Anchors, LLC · 2016
  5. 1 generation backK213391 High Retention Attachment SystemZest Anchors, LLC · 2022
  6. This deviceK233587 LOCATOR Angled Abutment (Various)Zest Anchors, LLC · 2024
  7. Descendant · cites it directly · 3 of its ownK243272 LOCATOR Angled AbutmentZest Anchors, LLC · 2025
  8. Descendant · 2 generations on · 2 of its ownK250721 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025
  9. Descendant · 3 generations on · 1 of its ownK252944 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025
  10. Descendant · 4 generations on · 0 of its ownK260555 LOCATOR® Angled AbutmentZest Anchors, LLC · 2026
Show all 15 generations
  1. Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
  2. 14 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
  3. 13 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
  4. 12 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
  5. 11 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
  6. 10 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
  7. 9 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
  8. 8 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
  9. 7 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
  10. 6 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
  11. 5 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
  12. 4 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
  13. 3 generations backK150295 LOCATOR RTxZest Anchors, Inc. · 2015
  14. 2 generations backK151789 LOCATOR F-Tx Attachment SystemZest Anchors, LLC · 2016
  15. 1 generation backK213391 High Retention Attachment SystemZest Anchors, LLC · 2022
  16. This deviceK233587 LOCATOR Angled Abutment (Various)Zest Anchors, LLC · 2024

Most influential descendants

Showing 4 of 4 · See all
  • K243272LOCATOR Angled AbutmentZest Anchors, LLC · 2025 · cites it directly3descendants
  • K250721LOCATOR® Angled AbutmentZest Anchors, LLC · 2025 · 2 generations on2descendants
  • K252944LOCATOR® Angled AbutmentZest Anchors, LLC · 2025 · 3 generations on1descendant
  • K260555LOCATOR® Angled AbutmentZest Anchors, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K894595Bonefit R Screw ImplantsInstitut Straumann AG1990—
−14K984104Iti Dental Implant SystemStraumann USA19991
−13K993595Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon…Nobel Biocare Uas, Inc.2000—
−12K023113Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc.200227
−11K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc.2004—
−10K050258Groovy ImplantsNobel Biocare AB200528
−9K061003SFB & CFB ImplantsNobel Biocare AB2006—
−8K071370Nobelactive Internal Connection ImplantNobel Biocare AB20074
−7K101732Astra Tech Implant SystemAstra Tech AB2011—
−6K111287Astra Tech Implant SystemAstra Tech AB2011—
−5K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011—
−4K120414Osseospeed PlusAstra Tech AB2012—
−3K150295LOCATOR RTxZest Anchors, Inc.2015—
−2K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC2016—
−1K213391High Retention Attachment SystemZest Anchors, LLC2022—
0 (this device)K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC2024—
+1K243272LOCATOR Angled AbutmentZest Anchors, LLC2025—
+2K250721LOCATOR® Angled AbutmentZest Anchors, LLC2025—
+3K252944LOCATOR® Angled AbutmentZest Anchors, LLC2025—
+4K260555LOCATOR® Angled AbutmentZest Anchors, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198210
198510
198620
198720
198810
198950
199050
199110
199220
1993110
1994100
1995100
1996110
199760
199870
199970
200030
200130
2002110
200370
200450
200540
200610
200760
200840
200930
201050
201130
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202530
202610
FIG. 1 — Lineage of K233587, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222288 DESS Dental Smart Solutionsscore 30.7 · 19 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K213391High Retention Attachment System
Summary page 5
…10(k) Number Locator High Retention Attachment System (LOCATOR FIXED): Zest Anchors, LLC K213391 Reference Devices 510(k) Number Straumann BLX Line Extension - New Ab…
Zest Anchors, LLC2022—
†K190040Straumann BLX Line Extension - New AbutmentsInstitut Straumann AG2019—
†K072878Modification to: Locator Implant AnchorZest Anchors, Inc.20071
†K173961Straumann BLX Implant SystemInstitut Straumann AG2018—
†K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG2018—
†K210855Straumann BLX Implant SystemInstitut Straumann AG2021—
†K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG2022—

Also cleared against K213391: 1 other device →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K243272LOCATOR Angled AbutmentZest Anchors, LLC20253

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 34 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
  • 16 of the 154 ancestors have a recall of any class.
  • Of its descendants, K243272 (Zest Anchors, LLC, 2025) has gone furthest, with 3 descendants of its own.
  • 1 other device also cites its predicate K213391.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · NHA

40in 2025

2007: 382008: 312009: 302010: 192011: 312012: 252013: 222014: 272015: 292016: 382017: 312018: 312019: 282020: 382021: 292022: 332023: 512024: 432025: 402026 (partial year): 23
2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007: 91 days median2008: 90 days median2009: 95 days median2010: 162 days median2011: 130 days median2012: 171 days median2013: 184 days median2014: 160 days median2015: 151 days median2016: 202 days median2017: 188 days median2018: 200 days median2019: 160 days median2020: 153 days median2021: 211 days median2022: 142 days median2023: 147 days median2024: 158 days median2025: 147 days median2026 (partial year): 169 days median
2007high 211 (2021) · low 90 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NHA

1in 2025

2007: 12008: 22011: 52012: 12013: 12015: 12016: 362017: 22018: 12020: 72023: 32025: 12026 (partial year): 3
2007high 36 (2016) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHA

838in 2025

2007: 12008: 82009: 302010: 612011: 562012: 52013: 1432014: 1462015: 8582016: 3142017: 5772018: 5912019: 5302020: 4582021: 5462022: 4972023: 6182024: 6352025: 838
2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007389111
2008319028
20093095030
201019162061
201131130556
20122517115
2013221841143
2014271600146
2015291511858
20163820236314
2017311882577
2018312001591
2019281600530
2020381537458
2021292110546
2022331420497
2023511473618
2024431580635
2025401471838
2026231693—

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.

Cite this page

510(k) Report. “K233587: LOCATOR Angled Abutment (Various).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233587

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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