510(k) · Cleared
Cleared4.0MM Simpler One Threaded Dental Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vancouver Implant Resources, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Feb 23, 1998 after a 94-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Feb 23, 1998
- Review
- 94 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK974401 4.0MM Simpler One Threaded Dental ImplantVancouver Implant Resources, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK991250 Quantum Versatility Implant SystemQuantum Bioengineering, Ltd. · 2001
- Descendant · 2 generations on · 1 of its ownK112279 Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK130787 Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK011574 Uniplant Dental Implant SystemUniversal Implant Systems, Inc. · 2001
Most influential descendants
Showing 4 of 4 · See all- K991250Quantum Versatility Implant SystemQuantum Bioengineering, Ltd. · 2001 · cites it directly2descendants
- K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2012 · 2 generations on1descendant
- K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd. · 2013 · 2 generations on0descendants
- K011574Uniplant Dental Implant SystemUniversal Implant Systems, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974401 | 4.0MM Simpler One Threaded Dental Implant | Vancouver Implant Resources, Inc. | 1998 | — |
| +1 | K991250 | Quantum Versatility Implant System | Quantum Bioengineering, Ltd. | 2001 | — |
| +2 | K112279 | Quantum Dental Implant System | Quantum Bioengineering, Ltd. | 2012 | — |
| +2 | K130787 | Quantum Dental Implant System | Quantum Bioengineering, Ltd. | 2013 | — |
| +1 | K011574 | Uniplant Dental Implant System | Universal Implant Systems, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K991250 (Quantum Bioengineering, Ltd., 2001) 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 | — |
What is it indicated for?
For use as an intra-bony, supporting component in the oral cavity to support crowns, bridges, and overdentures when replacing missing teeth.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974401 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974401: 4.0MM Simpler One Threaded Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974401
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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