510(k) · Cleared
Recalled · Class II · 2019Locator Overdenture Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zest Anchors, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Jun 6, 2012 as substantially equivalent to K092594 (Ace Surgical Supply Co., Inc., 2009) after a 135-day review. Its family tree reaches back 4 generations to 2002. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 6, 2012
- Review
- 135 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K021045 (2002). 10 ancestors in all, the oldest K934668 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK021045 Era ImplantSterngold · 2002
- 3 generations backK070601 Mini Drive-Lock Dental Implant SystemIntra-Lock International · 2007
- 2 generations backK073343 Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc. · 2008
- 1 generation backK092594 Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX…Ace Surgical Supply Co., Inc. · 2009
- This deviceK120198 Locator Overdenture Implant SystemZest Anchors, LLC · 2012
- Descendant · cites it directly · 0 of its ownK203701 Locator Overdenture Implant SystemIvory Super Holdco Inc. / Zest Anchors, LLC · 2021
- Descendant · cites it directly · 0 of its ownK133327 Saturno (TM) Overdenture Implant SystemZest Anchors, LLC · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021045 | Era Implant | Sterngold | 2002 | — |
| −3 | K070601 | Mini Drive-Lock Dental Implant System | Intra-Lock International | 2007 | — |
| −2 | K073343 | Ace Surgical Secure-Mini Implant System, Model 09-270X-XX | Ace Surgical Supply Co., Inc. | 2008 | — |
| −1 | K092594 | Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX… | Ace Surgical Supply Co., Inc. | 2009 | — |
| 0 (this device) | K120198 | Locator Overdenture Implant System | Zest Anchors, LLC | 2012 | — |
| +1 | K203701 | Locator Overdenture Implant System | Ivory Super Holdco Inc. / Zest Anchors, LLC | 2021 | — |
| +1 | K133327 | Saturno (TM) Overdenture Implant System | Zest Anchors, LLC | 2014 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K092594 | Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXSummary page 1…prepared: April130, 2012 C) Predicate Device: *Ace Surgical Supply Co., Inc., Ace Surgical Secure-Mini Tm LOCATOR® Implant System (K092594) D) Intended Use: The LOCATOR® Overdenture Implant System is designed to retain overdentures or partial dentures i… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2019 | Class II | Z-2425-2020 | Process control | The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K203701 (Ivory Super Holdco Inc. / Zest Anchors, LLC, 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K092594.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 maxilia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120198 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120198: 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/K120198
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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