510(k) Report

510(k) · Cleared

Cleared

LOCATOR® Angled Abutment

K252944510(k) SpecialCleared Oct 15, 202530-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 Oct 15, 2025 as substantially equivalent to K250721 (Zest Anchors, LLC, 2025) after a 30-day review. Its family tree reaches back 18 generations to 1990. 1 later device descends from it.

Decided
Oct 15, 2025
Review
30 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
1

Its longest line of descent runs back 18 generations to K894595 (1990). 157 ancestors in all, the oldest K781060 (1978). 1 later device descends 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 ancestor2026: 1 descendant clearedReference device: K151621 · BioHorizons CAD/CAM Abutments · BioHorizons Implant Systems, Inc. · 2016Reference device: K240187 · Tapered Pro Conical Implant System · BioHorizons Implant Systems, Inc. · 2024Reference device: K192218 · Custom Legacy and Custom InterActive Titanium Abutments · Implant Direct Sybron Manufacturing, LLC · 2020K894595 · 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 · 2022K233587 · LOCATOR Angled Abutment (Various) · Zest Anchors, LLC · 2024K243272 · LOCATOR Angled Abutment · Zest Anchors, LLC · 2025K250721 · LOCATOR® Angled Abutment · Zest Anchors, LLC · 202519801990200020102020
Other ancestors, by generationDescendants, by generation 6 generations back: 1 other ancestor8 generations back: 15 other ancestors9 generations back: 20 other ancestors10 generations back: 18 other ancestors11 generations back: 26 other ancestors12 generations back: 29 other ancestors13 generations back: 7 other ancestors14 generations back: 3 other ancestors15 generations back: 11 other ancestors16 generations back: 8 other ancestors17 generations back: 1 other ancestor 1 generation forward: 1 descendant K250721 · LOCATOR® Angled Abutment · Zest Anchors, LLC · 2025K243272 · LOCATOR Angled Abutment · Zest Anchors, LLC · 2025K233587 · LOCATOR Angled Abutment (Various) · Zest Anchors, LLC · 2024K213391 · 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 · 18 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
  2. 14 generations between
  3. 3 generations backK233587 LOCATOR Angled Abutment (Various)Zest Anchors, LLC · 2024
  4. 2 generations backK243272 LOCATOR Angled AbutmentZest Anchors, LLC · 2025
  5. 1 generation backK250721 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025
  6. This deviceK252944 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025
  7. Descendant · cites it directly · 0 of its ownK260555 LOCATOR® Angled AbutmentZest Anchors, LLC · 2026
Show all 18 generations
  1. Root · 18 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
  2. 17 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
  3. 16 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
  4. 15 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
  5. 14 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
  6. 13 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
  7. 12 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
  8. 11 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
  9. 10 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
  10. 9 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
  11. 8 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
  12. 7 generations backK120414 Osseospeed PlusAstra Tech AB · 2012
  13. 6 generations backK150295 LOCATOR RTxZest Anchors, Inc. · 2015
  14. 5 generations backK151789 LOCATOR F-Tx Attachment SystemZest Anchors, LLC · 2016
  15. 4 generations backK213391 High Retention Attachment SystemZest Anchors, LLC · 2022
  16. 3 generations backK233587 LOCATOR Angled Abutment (Various)Zest Anchors, LLC · 2024
  17. 2 generations backK243272 LOCATOR Angled AbutmentZest Anchors, LLC · 2025
  18. 1 generation backK250721 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025
  19. This deviceK252944 LOCATOR® Angled AbutmentZest Anchors, LLC · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K260555LOCATOR® Angled AbutmentZest Anchors, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K894595Bonefit R Screw ImplantsInstitut Straumann AG1990—
−17K984104Iti Dental Implant SystemStraumann USA19991
−16K993595Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon…Nobel Biocare Uas, Inc.2000—
−15K023113Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc.200227
−14K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc.2004—
−13K050258Groovy ImplantsNobel Biocare AB200528
−12K061003SFB & CFB ImplantsNobel Biocare AB2006—
−11K071370Nobelactive Internal Connection ImplantNobel Biocare AB20074
−10K101732Astra Tech Implant SystemAstra Tech AB2011—
−9K111287Astra Tech Implant SystemAstra Tech AB2011—
−8K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011—
−7K120414Osseospeed PlusAstra Tech AB2012—
−6K150295LOCATOR RTxZest Anchors, Inc.2015—
−5K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC2016—
−4K213391High Retention Attachment SystemZest Anchors, LLC2022—
−3K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC2024—
−2K243272LOCATOR Angled AbutmentZest Anchors, LLC2025—
−1K250721LOCATOR® Angled AbutmentZest Anchors, LLC2025—
0 (this device)K252944LOCATOR® Angled AbutmentZest Anchors, LLC2025—
+1K260555LOCATOR® 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
202610
FIG. 1 — Lineage of K252944, 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
*K250721LOCATOR® Angled Abutment
Summary page 6
…510(k) Number LOCATOR Angled Abutment: Zest Anchors, LLC K250721 Reference Devices 510(k) Number BioHorizons CAD/C…
Zest Anchors, LLC2025—
†K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.2016—
†K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.2024—
†K192218Custom Legacy and Custom InterActive Titanium AbutmentsImplant Direct Sybron Manufacturing, LLC2020—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260

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 35 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
  • 16 of the 157 ancestors have a recall of any class.
  • Of its descendants, K260555 (Zest Anchors, LLC, 2026) has gone furthest, with 0 descendants of its own.

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. 2025, 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. “K252944: LOCATOR® Angled Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252944

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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