510(k) · Cleared
ClearedScalloped Endopore Endosseous Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innova Life Sciences Corp. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 14, 2004 as substantially equivalent to K926354 (Innova Corp., 1995) and 2 other predicates after a 27-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Dec 14, 2004
- Review
- 27 days
- Class
- Class II
- Product code
- NHA
- 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 deviceK043190 Scalloped Endopore Endosseous Dental Implant SystemInnova Life Sciences Corp. · 2004
- Descendant · cites it directly · 0 of its ownK052951 Endopore Anatomic Endosseous Dental Implant SystemInnova Life Sciences Corp. · 2006
Most influential descendants
Showing 1 of 1 · See all- K052951Endopore Anatomic Endosseous Dental Implant SystemInnova Life Sciences Corp. · 2006 · 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) | K043190 | Scalloped Endopore Endosseous Dental Implant System | Innova Life Sciences Corp. | 2004 | — |
| +1 | K052951 | Endopore Anatomic Endosseous Dental Implant System | Innova Life Sciences Corp. | 2006 | — |
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 |
|---|---|---|
| 2006 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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…seous Implant (DZE) ; Endosseous Dental Implant Abutment (NHA) 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). Intended Use… | 1995 |
| * | K971196 | Endopore Endosseous Dental Implant SystemSummary page 1…us Dental Implant Abutment (NHA) 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). Intended Use The En… | 1997 |
| * | K032140 | 5.0 X 5MM Endopore Endosseous Dental Implant SystemSummary page 1…re® 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). Intended Use The Endopore Implant is indicated for use in the upper or lower jaw arches to provide s… | 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 |
|---|---|---|---|
| K052951 | Endopore Anatomic Endosseous Dental Implant System | 2006 | 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, K052951 (Innova Life Sciences Corp., 2006) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K926354.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
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/K043190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043190: Scalloped Endopore 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/K043190
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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