510(k) · Cleared
ClearedEndopore Anatomic 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. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 27, 2006 as substantially equivalent to K043190 (Innova Life Sciences Corp., 2004) and 3 other predicates after a 99-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Jan 27, 2006
- Review
- 99 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K971196 (1997). 4 ancestors in all, the oldest K926354 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK971196 Endopore Endosseous Dental Implant SystemInnova Corp. · 1997
- 2 generations backK032140 5.0 X 5MM Endopore Endosseous Dental Implant SystemInnova Life Sciences Corp. · 2003
- 1 generation backK043190 Scalloped Endopore Endosseous Dental Implant SystemInnova Life Sciences Corp. · 2004
- This deviceK052951 Endopore Anatomic Endosseous Dental Implant SystemInnova Life Sciences Corp. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971196 | Endopore Endosseous Dental Implant System | Innova Corp. | 1997 | — |
| −2 | K032140 | 5.0 X 5MM Endopore Endosseous Dental Implant System | Innova Life Sciences Corp. | 2003 | — |
| −1 | K043190 | Scalloped Endopore Endosseous Dental Implant System | Innova Life Sciences Corp. | 2004 | — |
| 0 (this device) | 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 |
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? (4)
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 |
|---|---|---|---|
| * | K043190 | Scalloped Endopore Endosseous Dental Implant SystemSummary page 1…e Endosseous Implant (DZE); Endosseous Dental Implant Abutment (NHA) Predicate Devices Scalloped Endopore® Endosseous Dental Implant System (1K043190); and Endopore®V Endosseous Dental Implant System in lengths of 7, 9, or 12 mm with diameter of 4.1 mm (1(926354); lengths of 7,… | 2004 |
| * | K926354 | Endo-Pore Endosseous Dental Implant SystemSummary page 1…Scalloped Endopore® Endosseous Dental Implant System (1K043190); and Endopore®V Endosseous Dental Implant System in lengths of 7, 9, or 12 mm with diameter of 4.1 mm (1(926354); lengths of 7, 9, or 12 mm with diameter of 5 mm (K(971196); and length of 5 mm length with diameter of 5 mm (032140). Intended… | 1995 |
| * | K971196 | Endopore Endosseous Dental Implant SystemSummary page 1…190); and Endopore®V Endosseous Dental Implant System in lengths of 7, 9, or 12 mm with diameter of 4.1 mm (1(926354); lengths of 7, 9, or 12 mm with diameter of 5 mm (K(971196); and length of 5 mm length with diameter of 5 mm (032140). Intended Use ENDOPORE Anatomic dental implants may be used as artif… | 1997 |
| * | K032140 | 5.0 X 5MM Endopore Endosseous Dental Implant SystemSummary page 1…engths of 7, 9, or 12 mm with diameter of 4.1 mm (1(926354); lengths of 7, 9, or 12 mm with diameter of 5 mm (K(971196); and length of 5 mm length with diameter of 5 mm (032140). Intended Use ENDOPORE Anatomic dental implants may be used as artificial root components to support a prosthesis in an edentu… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 4 ancestors has a recall.
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?
ENDOPORE Anatomic dental implants may be used as artificial root components to support a prosthesis in an edentulous or partially edentulous mandible or maxilla. ENDOPORE Anatomic dental implants are provided in three diameters, each intended for surgical placement into specific regions of the mandible and maxilla. Diameters and their corresponding regions are: 3.75 mm provided in lengths of 10, 12, and 15 mm for the anterior mandible 5.0 mm provided in…
Read the full statement (182 words)
ENDOPORE Anatomic dental implants may be used as artificial root components to support a prosthesis in an edentulous or partially edentulous mandible or maxilla.
ENDOPORE Anatomic dental implants are provided in three diameters, each intended for surgical placement into specific regions of the mandible and maxilla. Diameters and their corresponding regions are:
3.75 mm provided in lengths of 10, 12, and 15 mm for the anterior mandible
5.0 mm provided in lengths of 8.5, 10, 12, and 15 mm for the anterior maxilla,
and
4.5 nun provided in lengths of 8.5, 10, 12, and 15 mm for both the posterior mandible and posterior maxilla.
The appropriate diameter of implant corresponding to the planned placement region should be selected. In addition, as with all dental implants, appropriate preoperative buccolingual width and crestal bone height measurements of the planned site should be made to ensure that adequate alveolar bone volume is available to accommodate the diameter and length of implant selected. If bone volume is not adequate, a press-fit ENDOPORE or threaded ENTEGRA implant of appropriate diameter and length may be considered for placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052951: Endopore Anatomic 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/K052951
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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