510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Modification to: Locator Implant Anchor

K072878510(k) SpecialCleared Dec 3, 200755-day reviewClass II21 CFR 872.3630Recalls 1

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 Dec 3, 2007 after a 55-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 178 later devices descend from it. It has been recalled once.

Decided
Dec 3, 2007
Review
55 days
Class
Class II
Product code
NHA
Recalls
1
Predicates
0

178 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2018: 7 descendants cleared2015: 6 descendants cleared2016: 3 descendants cleared2022: 20 descendants cleared2009: 1 descendant cleared2017: 1 descendant cleared2012: 1 descendant cleared2013: 2 descendants cleared2010: 1 descendant cleared2024: 25 descendants cleared2019: 10 descendants cleared2020: 14 descendants cleared2025: 29 descendants cleared2021: 13 descendants cleared2026: 18 descendants cleared2023: 23 descendants cleared2014: 4 descendants cleared20052010201520202025
  1. This deviceK072878 Modification to: Locator Implant AnchorZest Anchors, Inc. · 2007
  2. Descendant · cites it directly · 134 of its ownK092594 Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX…Ace Surgical Supply Co., Inc. · 2009
  3. Descendant · 2 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
  4. Descendant · 3 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
  5. Descendant · 3 generations on · 109 of its ownK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
  6. Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015

Showing 5 of 178 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12012: 12013: 22014: 42015: 62016: 32017: 12018: 72019: 102020: 142021: 132022: 202023: 232024: 252025: 292026: 18
2009high 29 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 178 · See all
  • K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXAce Surgical Supply Co., Inc. · 2009 · cites it directly134descendants
  • K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 2 generations on127descendants
  • K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 3 generations on123descendants
  • K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc. · 2014 · 3 generations on109descendants
  • K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on89descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K072878Modification to: Locator Implant AnchorZest Anchors, Inc.2007—
+1K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX…Ace Surgical Supply Co., Inc.2009—
+2K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013—
+3K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014—
+3K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart…Neodent USA, Inc.2014—
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201210
201320
201440
201560
201630
201710
201870
2019100
2020140
2021130
2022200
2023230
2024250
2025290
2026180
FIG. 1 — Lineage of K072878, 2007–2026Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (178)

See all 178

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

NumberDeviceApplicantDecidedDescendants
K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXAce Surgical Supply Co., Inc.2009134
K170588DESS Dental Smart SolutionsTerrats Medical SL201786
K150295LOCATOR RTxZest Anchors, Inc.201542
K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168
K142167Medentika Abutment SystemMedentika GmbH20157
K201323INNO SLA Submerged Implant SystemCowellmedi Co., Ltd.20222
K171197Zuga Dental Implant SystemZuga Medical, Inc.20180

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 16, 2014Class IIZ-0935-2014Unknown/Undetermined by firmZest Anchors, LLC is voluntarily recalling specific lots of LOCATOR Implant Attachment Systems because it is currently provided with a label that indicates that the final torque applied to the abutment should be 30 N-cm. It was recently…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K092594 (Ace Surgical Supply Co., Inc., 2009) has gone furthest, with 134 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. 2007, 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—

More from Zest Anchors, Inc.

14 FDA decisions under this applicant name. See the company

  • K150295LOCATOR RTxZest Anchors, Inc. · 2015
  • K083324Locator Implant Anchor Attachment SystemZest Anchors, Inc. · 2009
  • 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

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The NHA category page

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  • K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A. · 2026

https://510kreport.com/device/K072878 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072878: Modification to: Locator Implant Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072878

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026