510(k) · Cleared
ClearedOsseotite Iol Implants and Osseotite Certain Iol Implants
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 Sep 16, 2003 as substantially equivalent to K014235 (Implant Innovations, Inc., 2002) and 5 other predicates after a 112-day review. Its family tree reaches back 4 generations to 1993. 320 later devices descend from it.
- Decided
- Sep 16, 2003
- Review
- 112 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K925765 (1993). 11 ancestors in all, the oldest K874590 (1988). 320 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 3 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 2 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 1 generation backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- This deviceK031632 Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc. · 2003
- Descendant · cites it directly · 317 of its ownK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- Descendant · cites it directly · 312 of its ownK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- Descendant · cites it directly · 213 of its ownK033430 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685…Implant Innovations, Inc. · 2003
- Descendant · 2 generations on · 211 of its ownK063286 Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · Recalled
- Descendant · cites it directly · 209 of its ownK063341 3I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · Recalled
Showing 5 of 320 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 320 · See all- K051189Prevail Dental ImplantsImplant Innovations, Inc. · 2005 · cites it directly317descendants
- K0514613I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005 · cites it directly312descendants
- K0334303I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611…Implant Innovations, Inc. · 2003 · cites it directly213descendants
- K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · 2 generations on211descendants
- K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · cites it directly209descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −3 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −2 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −1 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| 0 (this device) | K031632 | Osseotite Iol Implants and Osseotite Certain Iol Implants | Implant Innovations, Inc. | 2003 | — |
| +1 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| +1 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| +1 | K033430 | 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610… | Implant Innovations, Inc. | 2003 | — |
| +2 | K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | Implant Innovations, Inc. | 2007 | 5 |
| +1 | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | 10 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 8 | 0 |
| 2014 | 11 | 0 |
| 2015 | 12 | 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? (6)
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 |
|---|---|---|---|
| * | K014235 | Osseotite NT Dental Implants & Accessories | 2002 |
| * | K972444 | 3I Innovative Implants and Cover ScrewsSummary page 1…Devices Panel 21 CFR 0 872.3640 Predicate KO14235 - OSSEOTITEO NTTMDental Implants Devices K972444 - 3i Innovative Implants and Cover Screws K935544 - Threaded Self-Tapping Threaded Implants… | 1997 |
| * | K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants ModificationSummary page 1…KO14235 - OSSEOTITEO NTTMDental Implants Devices K972444 - 3i Innovative Implants and Cover Screws K935544 - Threaded Self-Tapping Threaded Implants K980549 - OSSEOTITE Dental Implants… | 1995 |
| * | K980549 | Osseotite Dental Implant SystemSummary page 1…K972444 - 3i Innovative Implants and Cover Screws K935544 - Threaded Self-Tapping Threaded Implants K980549 - OSSEOTITE Dental Implants K983347 - OSSEOTITE Dental Implants K… | 1998 |
| * | K983347 | Osseotite Dental ImplantsSummary page 1…K935544 - Threaded Self-Tapping Threaded Implants K980549 - OSSEOTITE Dental Implants K983347 - OSSEOTITE Dental Implants KO22009 - 3i Dental Implants Performance Perfor… | 1999 |
| * | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | 2002 |
What descends from it? (320)
See all 3207 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051189 | Prevail Dental Implants | 2005 | 317 |
| K051461 | 3I Osseotite Dental Implants | 2005 | 312 |
| K033430 | 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611… | 2003 | 213 |
| K063341 | 3I Osseotite Certain Dental Implants | 2007 | 209 |
| K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | 2007 | 28 |
| K061629 | Certain Prevail Dental Implant | 2007 | 4 |
| 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 10 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K051189 (Implant Innovations, Inc., 2005) has gone furthest, with 317 descendants of its own.
- 10 other devices also cite its predicate K014235.
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?
3i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031632 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031632: Osseotite Iol Implants and Osseotite Certain Iol Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031632
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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