510(k) · Cleared
ClearedHybrid Endopore Endosseous Dental Implant
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 Apr 9, 2004 as substantially equivalent to K926354 (Innova Corp., 1995) and 2 other predicates after a 22-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Apr 9, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K971196 (1997). 3 ancestors in all, the oldest K926354 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK971196 Endopore Endosseous Dental Implant SystemInnova Corp. · 1997
- 1 generation backK032140 5.0 X 5MM Endopore Endosseous Dental Implant SystemInnova Life Sciences Corp. · 2003
- This deviceK040714 Hybrid Endopore Endosseous Dental ImplantInnova Corp. · 2004
- Descendant · cites it directly · 0 of its ownK042971 Titan Dental Implant SystemTitan Implants, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K042971Titan Dental Implant SystemTitan Implants, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971196 | Endopore Endosseous Dental Implant System | Innova Corp. | 1997 | — |
| −1 | K032140 | 5.0 X 5MM Endopore Endosseous Dental Implant System | Innova Life Sciences Corp. | 2003 | — |
| 0 (this device) | K040714 | Hybrid Endopore Endosseous Dental Implant | Innova Corp. | 2004 | — |
| +1 | K042971 | Titan Dental Implant System | Titan Implants, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K926354 | Endo-Pore Endosseous Dental Implant SystemSummary page 1…on Name Endosseous Implant (DZE) Predicate Devices Endopore® Endosseous Dental Implant System in 4.1 mm diameter (K926354) and 5.0 mm diameter (K971196); 5 mm long x 5.0 mm diameter Endopore Endosseous Dental Implant System (K032140). Inten(ded U… | 1995 |
| * | K971196 | Endopore Endosseous Dental Implant SystemSummary page 1…Endosseous Implant (DZE) Predicate Devices Endopore® Endosseous Dental Implant System in 4.1 mm diameter (K926354) and 5.0 mm diameter (K971196); 5 mm long x 5.0 mm diameter Endopore Endosseous Dental Implant System (K032140). Inten(ded Use T… | 1997 |
| * | K032140 | 5.0 X 5MM Endopore Endosseous Dental Implant SystemSummary page 1…® Endosseous Dental Implant System in 4.1 mm diameter (K926354) and 5.0 mm diameter (K971196); 5 mm long x 5.0 mm diameter Endopore Endosseous Dental Implant System (K032140). Inten(ded Use The Endopore Implant is indicated for use in the upper or lower jaw arches to prov… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042971 | Titan Dental Implant System | 2005 | 0 |
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K042971 (Titan Implants, Inc., 2005) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K926354.
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 endosseous dental implant in the upper or lower jaw arches to provide
support for prosthetic devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040714: Hybrid Endopore Endosseous Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040714
Report an extraction error
Are you the manufacturer?
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