510(k) · Cleared
ClearedAce Srew Dentla 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 Jun 5, 1996 after a 251-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jun 5, 1996
- Review
- 251 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK954513 Ace Srew Dentla Implant SystemAce Surgical Supply Co., Inc. · 1996
- Descendant · cites it directly · 2 of its ownK093518 Ace Surgical Secure Locator 3.25 Implant SystemAce Surgical Supply Co., Inc. · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK131701 Z5MLB, Z5MLCZ-Systems AG · 2013
- Descendant · cites it directly · 1 of its ownK041759 Ace Connect Internal ConnectionAce Surgical Supply Co., Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK200386 Z5-BLZ-Systems AG · 2020
- Descendant · cites it directly · 0 of its ownK103790 Ace Trimark Tricam Dental ImplantAce Surgical Supply Company, Inc. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K093518Ace Surgical Secure Locator 3.25 Implant SystemAce Surgical Supply Co., Inc. · 2010 · cites it directly2descendants
- K131701Z5MLB, Z5MLCZ-Systems AG · 2013 · 2 generations on1descendant
- K041759Ace Connect Internal ConnectionAce Surgical Supply Co., Inc. · 2004 · cites it directly1descendant
- K200386Z5-BLZ-Systems AG · 2020 · 3 generations on0descendants
- K103790Ace Trimark Tricam Dental ImplantAce Surgical Supply Company, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954513 | Ace Srew Dentla Implant System | Ace Surgical Supply Co., Inc. | 1996 | — |
| +1 | K093518 | Ace Surgical Secure Locator 3.25 Implant System | Ace Surgical Supply Co., Inc. | 2010 | 1 |
| +2 | K131701 | Z5MLB, Z5MLC | Z-Systems AG | 2013 | — |
| +1 | K041759 | Ace Connect Internal Connection | Ace Surgical Supply Co., Inc. | 2004 | — |
| +3 | K200386 | Z5-BL | Z-Systems AG | 2020 | — |
| +1 | K103790 | Ace Trimark Tricam Dental Implant | Ace Surgical Supply Company, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
4 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093518 (Ace Surgical Supply Co., Inc., 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K954513 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954513: Ace Srew Dentla 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/K954513
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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