510(k) · Cleared
Recalled · Class II · 20153I Innovative Implants and Cover Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Innovations, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Aug 26, 1997 after a 57-day review. The FDA summary names its predicate without a number. 335 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 26, 1997
- Review
- 57 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 2
- Predicates
- 0
335 later devices descend from it, 8 citing it directly.
- This deviceK972444 3I Innovative Implants and Cover ScrewsImplant Innovations, Inc. · 1997
- Descendant · cites it directly · 330 of its ownK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- Descendant · cites it directly · 320 of its ownK031632 Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc. · 2003
- Descendant · cites it directly · 319 of its ownK030614 3I Dental ImplantsImplant Innovations, Inc. · 2003
- Descendant · 2 generations on · 318 of its ownK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- Descendant · 2 generations on · 317 of its ownK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
Showing 5 of 335 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 335 · See all- K031475Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003 · cites it directly330descendants
- K031632Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc. · 2003 · cites it directly320descendants
- K0306143I Dental ImplantsImplant Innovations, Inc. · 2003 · cites it directly319descendants
- K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004 · 2 generations on318descendants
- K051189Prevail Dental ImplantsImplant Innovations, Inc. · 2005 · 2 generations on317descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972444 | 3I Innovative Implants and Cover Screws | Implant Innovations, Inc. | 1997 | — |
| +1 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| +1 | K031632 | Osseotite Iol Implants and Osseotite Certain Iol Implants | Implant Innovations, Inc. | 2003 | — |
| +1 | K030614 | 3I Dental Implants | Implant Innovations, Inc. | 2003 | — |
| +2 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| +2 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 9 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 8 | 0 |
| 2012 | 5 | 0 |
| 2013 | 8 | 0 |
| 2014 | 12 | 0 |
| 2015 | 13 | 0 |
| 2016 | 14 | 0 |
| 2017 | 14 | 0 |
| 2018 | 13 | 0 |
| 2019 | 18 | 0 |
| 2020 | 19 | 0 |
| 2021 | 19 | 0 |
| 2022 | 31 | 0 |
| 2023 | 32 | 0 |
| 2024 | 40 | 0 |
| 2025 | 38 | 0 |
| 2026 | 22 | 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? (2)
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 |
|---|---|---|---|
| * | — | 3i Endosseous Dental Implant Systems Named without a submission number | |
| * | — | ITI Straumann Dental Implant System Named without a submission number |
What descends from it? (335)
See all 3358 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031475 | Osseotite NT Certain Implants | 2003 | 330 |
| K031632 | Osseotite Iol Implants and Osseotite Certain Iol Implants | 2003 | 320 |
| K030614 | 3I Dental Implants | 2003 | 319 |
| K051461 | 3I Osseotite Dental Implants | 2005 | 312 |
| K033430 | 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611… | 2003 | 213 |
| K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | 2007 | 211 |
| K063341 | 3I Osseotite Certain Dental Implants | 2007 | 209 |
| K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | 2007 | 28 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2015 | Class II | Z-2521-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2500-2016 | Packaging | Pouches may not have been sealed during packing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031475 (Implant Innovations, Inc., 2003) has gone furthest, with 330 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?
Indications for use of the 3i Endosseous Dental Implant Systems are not altered by this submission. An Endosseous Dental Implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for prosthetic appliance attachment to restore a patient’s chewing function.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972444 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972444: 3I Innovative Implants and Cover Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972444
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