510(k) · Cleared
ClearedLocator Overdenture Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivory Super Holdco Inc. / Zest Anchors, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Apr 15, 2021 as substantially equivalent to K120198 (Zest Anchors, LLC, 2012) after a 118-day review. Its family tree reaches back 5 generations to 2002.
- Decided
- Apr 15, 2021
- Review
- 118 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K021045 (2002). 11 ancestors in all, the oldest K934668 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK021045 Era ImplantSterngold · 2002
- 4 generations backK070601 Mini Drive-Lock Dental Implant SystemIntra-Lock International · 2007
- 3 generations backK073343 Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc. · 2008
- 2 generations backK092594 Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX…Ace Surgical Supply Co., Inc. · 2009
- 1 generation backK120198 Locator Overdenture Implant SystemZest Anchors, LLC · 2012 · Recalled
- This deviceK203701 Locator Overdenture Implant SystemIvory Super Holdco Inc. / Zest Anchors, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K021045 | Era Implant | Sterngold | 2002 | — |
| −4 | K070601 | Mini Drive-Lock Dental Implant System | Intra-Lock International | 2007 | — |
| −3 | K073343 | Ace Surgical Secure-Mini Implant System, Model 09-270X-XX | Ace Surgical Supply Co., Inc. | 2008 | — |
| −2 | K092594 | Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX… | Ace Surgical Supply Co., Inc. | 2009 | — |
| −1 | K120198 | Locator Overdenture Implant System | Zest Anchors, LLC | 2012 | 1 |
| 0 (this device) | K203701 | Locator Overdenture Implant System | Ivory Super Holdco Inc. / Zest Anchors, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
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 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120198 | Locator Overdenture Implant SystemSummary page 4…ication: Class II, 21 CFR 872.3640 Product Code: DZE III. PREDICATE DEVICE(s) Primary Predicate: LOCATOR® Overdenture Implant System (K120198) Reference Device(s): Legacy2, Legacy3, Legacy4, SimplyLegacy2, SimplyLegacy3 Dental Implants (K192221) I… | 2012 |
| † | K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K120198.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The LOCATOR® Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilla. Immediate loading is indicated when good primary stability has been achieved and with appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203701 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203701: Locator Overdenture Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203701
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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