510(k) Report

510(k) · Cleared

Cleared

Locator Implant Anchor Attachment System

K083324510(k) SpecialCleared Feb 25, 2009105-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, Inc. · NHA Abutment, Implant, Dental, Endosseous

Cleared on Feb 25, 2009 after a 105-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 27 later devices descend from it.

Decided
Feb 25, 2009
Review
105 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
0

27 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2022: 5 descendants cleared2014: 3 descendants cleared2016: 2 descendants cleared2019: 4 descendants cleared2017: 1 descendant cleared2020: 2 descendants cleared2024: 3 descendants cleared2018: 2 descendants cleared2026: 2 descendants cleared2021: 2 descendants cleared2025: 1 descendant cleared20052010201520202025
  1. This deviceK083324 Locator Implant Anchor Attachment SystemZest Anchors, Inc. · 2009
  2. Descendant · cites it directly · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
  3. Descendant · 2 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
  4. Descendant · 3 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
  5. Descendant · 2 generations on · 4 of its ownK162482 A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017
  6. Descendant · 3 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2014: 32016: 22017: 12018: 22019: 42020: 22021: 22022: 52024: 32025: 12026: 2
2014high 5 (2022) · low 0 (2015)2026

Most influential descendants

Showing 5 of 27 · See all
  • K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · cites it directly25descendants
  • K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 2 generations on14descendants
  • K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 3 generations on7descendants
  • K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017 · 2 generations on4descendants
  • K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K083324Locator Implant Anchor Attachment SystemZest Anchors, Inc.2009—
+1K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.2014—
+2K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.2014—
+3K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.2016—
+2K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.2017—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201430
201620
201710
201820
201940
202020
202120
202250
202430
202510
202620
FIG. 1 — Lineage of K083324, 2009–2026Source: 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 510(k) statement (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 30.6 · 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (27)

See all 27

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425
K220612PrimeLOC Attachment SystemInnovative Product Brands, Inc.20220

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?

  • Of its descendants, K132125 (A.B. Dental Devices, Ltd., 2014) has gone furthest, with 25 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. 2009, 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 Implant Anchor Abutment for Endosseous Dental Implants is appropriate for use

with overdentures or partial dentures retained in whole or in part by endosseous implants in the

mandible or maxilla.

The Locator Implant Bar Attachment System for Endosseous Dental Implants is appropriate for

use with overdentures or partial dentures retained in whole or in part by bar splinted endosseous

implants in the mandible or maxilla.

Indications for use as stated in the FDA 510(k) statement.

More from Zest Anchors, Inc.

14 FDA decisions under this applicant name. See the company

  • K150295LOCATOR RTxZest Anchors, Inc. · 2015
  • K072878Modification to: Locator Implant AnchorZest Anchors, Inc. · 20071 recall
  • K042466X-2 Implant Abutment; Bar Male; Distal Extension MaleZest Anchors, Inc. · 2004
  • K033699Locator Bar Female, Locator Laser Bar Female, Locator Bar Cast-to Female, Models 08587, 08588, 08586Zest Anchors, Inc. · 2004
  • K994257Locator Implant AnchorZest Anchors, Inc. · 20002 recalls

Recent decisions in NHA

The NHA category page

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https://510kreport.com/device/K083324 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083324: Locator Implant Anchor 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/K083324

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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