510(k) · Cleared
Recalled · Class II · 2017Ace Surgical Secure Locator 3.25 Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ace Surgical Supply Co., Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 14, 2010 as substantially equivalent to K092594 (Ace Surgical Supply Co., Inc., 2009) and 1 other predicate after a 62-day review. Its family tree reaches back 4 generations to 2002. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 14, 2010
- Review
- 62 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K021045 (2002). 11 ancestors in all, the oldest K934668 (1994). 2 later devices descend from it, 1 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 deviceK093518 Ace Surgical Secure Locator 3.25 Implant SystemAce Surgical Supply Co., Inc. · 2010
- Descendant · cites it directly · 1 of its ownK131701 Z5MLB, Z5MLCZ-Systems AG · 2013
- Descendant · 2 generations on · 0 of its ownK200386 Z5-BLZ-Systems AG · 2020
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) | K093518 | Ace Surgical Secure Locator 3.25 Implant System | Ace Surgical Supply Co., Inc. | 2010 | — |
| +1 | K131701 | Z5MLB, Z5MLC | Z-Systems AG | 2013 | — |
| +2 | K200386 | Z5-BL | Z-Systems AG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 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? (2)
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…, EndosseOus Dental Implant Abutment, product code NHA Predicate device: ACE Surgical Secure-MMini Locators Implant System, K092594 ACE Screw Dental Implant System, K(954513 Reason tar Submission: Not previously marketed… | 2009 |
| * | K954513 | Ace Srew Dentla Implant SystemSummary page 1…lliSTif(CP.Orade 4) per ASTM F67standard. The screw implants, abutments and denture caps are Identical In materials and characterIstics to that cleared under K092594 and K954513. These screws are supplied sterile Instandard Twvek- tray packaging along With applicable instructions for use. The ACE SecUrr Lo… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131701 | Z5MLB, Z5MLC | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 22, 2017 | Class II | Z-1835-2017 | Labeling mix-ups | Incorrect device was packaged. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K131701 (Z-Systems AG, 2013) has gone furthest, with 1 descendant 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. 2010, 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 ACE Surgical Secure™ Locator® 3.25mm Implant System is designed to provide intra-bony long term fixation of denture installations in partially or fully edentulous patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093518 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093518: Ace Surgical Secure Locator 3.25 Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093518
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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