510(k) · Cleared
ClearedEndo-Pore Endosseous Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innova Corp. · DZE Implant, Endosseous, Root-Form
Cleared on Feb 13, 1995 after a 784-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 13, 1995
- Review
- 784 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK926354 Endo-Pore Endosseous Dental Implant SystemInnova Corp. · 1995
- Descendant · cites it directly · 1 of its ownK043190 Scalloped Endopore Endosseous Dental Implant SystemInnova Life Sciences Corp. · 2004
- Descendant · cites it directly · 1 of its ownK040714 Hybrid Endopore Endosseous Dental ImplantInnova Corp. · 2004
- Descendant · cites it directly · 0 of its ownK113113 Endosseous Dental ImplantOt Medical GmbH · 2012
- Descendant · cites it directly · 0 of its ownK052951 Endopore Anatomic Endosseous Dental Implant SystemInnova Life Sciences Corp. · 2006
- Descendant · 2 generations on · 0 of its ownK042971 Titan Dental Implant SystemTitan Implants, Inc. · 2005
Most influential descendants
Showing 5 of 5 · See all- K043190Scalloped Endopore Endosseous Dental Implant SystemInnova Life Sciences Corp. · 2004 · cites it directly1descendant
- K040714Hybrid Endopore Endosseous Dental ImplantInnova Corp. · 2004 · cites it directly1descendant
- K113113Endosseous Dental ImplantOt Medical GmbH · 2012 · cites it directly0descendants
- K052951Endopore Anatomic Endosseous Dental Implant SystemInnova Life Sciences Corp. · 2006 · cites it directly0descendants
- K042971Titan Dental Implant SystemTitan Implants, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926354 | Endo-Pore Endosseous Dental Implant System | Innova Corp. | 1995 | — |
| +1 | K043190 | Scalloped Endopore Endosseous Dental Implant System | Innova Life Sciences Corp. | 2004 | — |
| +1 | K040714 | Hybrid Endopore Endosseous Dental Implant | Innova Corp. | 2004 | — |
| +1 | K113113 | Endosseous Dental Implant | Ot Medical GmbH | 2012 | — |
| +1 | K052951 | Endopore Anatomic Endosseous Dental Implant System | Innova Life Sciences Corp. | 2006 | — |
| +2 | K042971 | Titan Dental Implant System | Titan Implants, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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, K043190 (Innova Life Sciences Corp., 2004) has gone furthest, with 1 descendant 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/K926354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K926354: Endo-Pore Endosseous Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926354
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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