510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Locator Implant Anchor

K994257510(k) TraditionalCleared Mar 17, 200092-day reviewClass II21 CFR 872.3640Recalls 2

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

Zest Anchors, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Mar 17, 2000 as substantially equivalent to K934668 (Zest Anchors, Inc., 1994) after a 92-day review. Its family tree reaches back 1 generation to 1994. 185 later devices descend from it. It has been recalled 2 times.

Decided
Mar 17, 2000
Review
92 days
Class
Class II
Product code
DZE
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K934668 (1994). 185 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2014: 11 descendants cleared2012: 4 descendants cleared2009: 2 descendants cleared2007: 1 descendant cleared2011: 2 descendants cleared2013: 3 descendants cleared2010: 1 descendant cleared2018: 8 descendants cleared2025: 25 descendants cleared2015: 7 descendants cleared2020: 13 descendants cleared2021: 14 descendants cleared2022: 18 descendants cleared2019: 12 descendants cleared2016: 7 descendants cleared2017: 3 descendants cleared2024: 20 descendants cleared2023: 19 descendants cleared2026: 15 descendants clearedK934668 · Zest Implant Anchor Advanced Generation (Dental) · Zest Anchors, Inc. · 19941990200020102020
Descendants, by generation 1 generation forward: 7 descendants2 generations forward: 9 descendants3 generations forward: 17 descendants4 generations forward: 28 descendants5 generations forward: 43 descendants6 generations forward: 33 descendants7 generations forward: 23 descendants8 generations forward: 9 descendants9 generations forward: 8 descendants10 generations forward: 6 descendants11 generations forward: 1 descendant12 generations forward: 1 descendant K934668 · Zest Implant Anchor Advanced Generation (Dental) · Zest Anchors, Inc. · 19940+5+10
  1. Root · 1 generation backK934668 Zest Implant Anchor Advanced Generation (Dental)Zest Anchors, Inc. · 1994
  2. This deviceK994257 Locator Implant AnchorZest Anchors, Inc. · 2000
  3. 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
  4. Descendant · 2 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
  5. Descendant · 3 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
  6. Descendant · 3 generations on · 109 of its ownK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
  7. Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015

Showing 5 of 185 descendants. See all descendants

Descendants cleared per year

2007: 12009: 22010: 12011: 22012: 42013: 32014: 112015: 72016: 72017: 32018: 82019: 122020: 132021: 142022: 182023: 192024: 202025: 252026: 15
2007high 25 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 185 · 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
−1K934668Zest Implant Anchor Advanced Generation (Dental)Zest Anchors, Inc.1994—
0 (this device)K994257Locator Implant AnchorZest Anchors, Inc.2000—
+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
200710
200920
201010
201120
201240
201330
2014110
201570
201670
201730
201880
2019120
2020130
2021140
2022180
2023190
2024200
2025250
2026150
FIG. 1 — Lineage of K994257, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 DZE? 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 DZE device

  1. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 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
*K934668Zest Implant Anchor Advanced Generation (Dental)
Summary page 1
…gally marketed device to which our firm is claiming equivalence is identified as the ZAAG Implant Anchor manufactured by Zest Anchors, Inc., and cleared for market under K934668. The predicate device is an abutment for endosseous implants which is intended for use with overdentures or partial dentures reta…
Zest Anchors, Inc.1994—

What descends from it? (185)

See all 185

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
K071838Neoss Various Titanium AbutmentsNeoss, Ltd.200774
K112787KeratorKj Meditech Co., Ltd.20123
K130618Sfi-AnchorCendres & Metaux SA20142
K142407Straight Stud AttachmentSterngold Dental, LLC20141
K132144KeratorLK Consulting Group USA, Inc.20140
K112333LRT AttachmentBcf Certification, Inc.20120

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…
Apr 9, 2008Not classifiedZ-0298-2009Nonconforming Material/ComponentThe recall was initiated after the firm discovered through a customer complaint that the Locator Abutments for 5.7 Screw-vent & Compatibles do not fit properly in all sizes of the Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implants…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • 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 DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

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

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
2007high 15 (2016) · low 0 (2011)2026

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

Adverse event reports per year · DZE

465,788in 2025

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, 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
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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
  • 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

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K994257 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994257: 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/K994257

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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