510(k) · Cleared
ClearedNanotite Dental 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 Feb 22, 2007 as substantially equivalent to K051461 (Implant Innovations, Inc., 2005) after a 185-day review. Its family tree reaches back 8 generations to 1993. 59 later devices descend from it.
- Decided
- Feb 22, 2007
- Review
- 185 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K925765 (1993). 61 ancestors in all, the oldest K781060 (1978). 59 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 7 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 6 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 5 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 4 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 3 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 2 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- This deviceK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- Descendant · cites it directly · 28 of its ownK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- Descendant · 2 generations on · 27 of its ownK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 22 of its ownK122300 T3 Dental ImplantBiomet 3i · 2013 · Recalled
- Descendant · 3 generations on · 21 of its ownK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- Descendant · 4 generations on · 19 of its ownK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP…Implant Innovations, Inc. · 2007 · cites it directly28descendants
- K100724Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · 2 generations on27descendants
- K122300T3 Dental ImplantBiomet 3i · 2013 · 3 generations on22descendants
- K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011 · 3 generations on21descendants
- K1330493I T3(R) External Hex Dental ImplantsBiomet 3i · 2014 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −7 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −6 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −5 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −4 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −3 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −2 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −1 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| 0 (this device) | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| +1 | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| +2 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| +3 | K122300 | T3 Dental Implant | Biomet 3i | 2013 | 3 |
| +3 | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| +4 | K133049 | 3I T3(R) External Hex Dental Implants | Biomet 3i | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1992 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K051461 | 3I Osseotite Dental ImplantsSummary page 1…Dental Devices Panel 21 CFR § 872.3640 Predicate 3i OSSEOTITE Dental Implants Devices K051461 Performance Performance standards have not been established by the FDA under S… | 2005 |
What descends from it? (59)
See all 593 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 8 of the 61 ancestors have a recall of any class.
- Of its descendants, K062636 (Implant Innovations, Inc., 2007) has gone furthest, with 28 descendants of its own.
- 6 other devices also cite its predicate K051461.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the maxilla and/or the mandible and splinted in the anterior region, immediate loading is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062432 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062432: Nanotite Dental Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062432
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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