510(k) · Cleared
ClearedOsseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP, Microminiplant, 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 Jun 1, 2007 as substantially equivalent to K014235 (Implant Innovations, Inc., 2002) and 13 other predicates after a 269-day review. Its family tree reaches back 9 generations to 1993. 28 later devices descend from it.
- Decided
- Jun 1, 2007
- Review
- 269 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 9 generations to K925765 (1993). 62 ancestors in all, the oldest K781060 (1978). 28 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 5 generations between
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- This deviceK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- Descendant · cites it directly · 27 of its ownK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 22 of its ownK122300 T3 Dental ImplantBiomet 3i · 2013 · Recalled
- Descendant · 2 generations on · 21 of its ownK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- Descendant · 3 generations on · 19 of its ownK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- Descendant · 4 generations on · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
Show all 9 generations
- Root · 9 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 8 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 7 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 6 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 5 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 4 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 3 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 2 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 1 generation backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- This deviceK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K100724Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · cites it directly27descendants
- K122300T3 Dental ImplantBiomet 3i · 2013 · 2 generations on22descendants
- K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011 · 2 generations on21descendants
- K1330493I T3(R) External Hex Dental ImplantsBiomet 3i · 2014 · 3 generations on19descendants
- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −8 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −7 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −6 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −5 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −4 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −3 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −2 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −1 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| 0 (this device) | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| +1 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| +2 | K122300 | T3 Dental Implant | Biomet 3i | 2013 | 3 |
| +2 | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| +3 | K133049 | 3I T3(R) External Hex Dental Implants | Biomet 3i | 2014 | — |
| +4 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (14)
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 & AccessoriesSummary page 1…Class II Classification Dental Devices Panel 21 CFR § 872.3640 Predicate OSSEOTITE NT Dental Implants - K014235 Devices 3i Innovation Implants and Cover Screws - K972444 Threaded/Self-Tapping Threa… | 2002 |
| * | K972444 | 3I Innovative Implants and Cover ScrewsSummary page 1…21 CFR § 872.3640 Predicate OSSEOTITE NT Dental Implants - K014235 Devices 3i Innovation Implants and Cover Screws - K972444 Threaded/Self-Tapping Threaded Implants - K935544 OSSEOTITE Dental implants -… | 1997 |
| * | K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants ModificationSummary page 1…Dental Implants - K014235 Devices 3i Innovation Implants and Cover Screws - K972444 Threaded/Self-Tapping Threaded Implants - K935544 OSSEOTITE Dental implants - K980549 OSSEOTITE Dental Implants - K983347… | 1995 |
| * | K980549 | Osseotite Dental Implant SystemSummary page 1…ion Implants and Cover Screws - K972444 Threaded/Self-Tapping Threaded Implants - K935544 OSSEOTITE Dental implants - K980549 OSSEOTITE Dental Implants - K983347 3i Dental Implants - K022009… | 1998 |
| * | K983347 | Osseotite Dental ImplantsSummary page 1…Threaded/Self-Tapping Threaded Implants - K935544 OSSEOTITE Dental implants - K980549 OSSEOTITE Dental Implants - K983347 3i Dental Implants - K022009 HA- Coated Endosseous Dental Implants - K955428… | 1999 |
| * | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsSummary page 1…OSSEOTITE Dental implants - K980549 OSSEOTITE Dental Implants - K983347 3i Dental Implants - K022009 HA- Coated Endosseous Dental Implants - K955428 3i OSSEOTITE NT Certain Impla… | 2002 |
| * | K955428 | 3I Hydroxylapatite Coated Standard Threaded & Self-Tapping ImplantsSummary page 1…OSSEOTITE Dental Implants - K983347 3i Dental Implants - K022009 HA- Coated Endosseous Dental Implants - K955428 3i OSSEOTITE NT Certain Implants - K031475 3i IOL Implants - K031632… | 1996 |
| * | K031475 | Osseotite NT Certain ImplantsSummary page 1…3i Dental Implants - K022009 HA- Coated Endosseous Dental Implants - K955428 3i OSSEOTITE NT Certain Implants - K031475 3i IOL Implants - K031632 3i Implants - K030614 OSS… | 2003 |
| * | K031632 | Osseotite Iol Implants and Osseotite Certain Iol ImplantsSummary page 1…HA- Coated Endosseous Dental Implants - K955428 3i OSSEOTITE NT Certain Implants - K031475 3i IOL Implants - K031632 3i Implants - K030614 OSSEOTITE NT Certain Implants - K041402… | 2003 |
| * | K030614 | 3I Dental ImplantsSummary page 1…K955428 3i OSSEOTITE NT Certain Implants - K031475 3i IOL Implants - K031632 3i Implants - K030614 OSSEOTITE NT Certain Implants - K041402 Prevail Implants - K051189… | 2003 |
| * | K041402 | Modification to Osseotite NT Certain ImplantsSummary page 1…s - K031475 3i IOL Implants - K031632 3i Implants - K030614 OSSEOTITE NT Certain Implants - K041402 Prevail Implants - K051189 3i OSSEOTITE Dental Implants - K051461… | 2004 |
| * | K051189 | Prevail Dental ImplantsSummary page 1…- K031632 3i Implants - K030614 OSSEOTITE NT Certain Implants - K041402 Prevail Implants - K051189 3i OSSEOTITE Dental Implants - K051461 NanoTite Dental Implants - K062432 ==… | 2005 |
| * | K051461 | 3I Osseotite Dental ImplantsSummary page 1…OSSEOTITE NT Certain Implants - K041402 Prevail Implants - K051189 3i OSSEOTITE Dental Implants - K051461 NanoTite Dental Implants - K062432 Device Description BIOMET 3i Dental Implants are… | 2005 |
| * | K062432 | Nanotite Dental Implants Cleared while this submission was under review Summary page 1…Prevail Implants - K051189 3i OSSEOTITE Dental Implants - K051461 NanoTite Dental Implants - K062432 Device Description BIOMET 3i Dental Implants are provided with the proprietary OSSEOTITE… | 2007 |
What descends from it? (28)
See all 281 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100724 | Osseotite II Model Xifossxxx | 2011 | 27 |
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 11 months on median.
- 8 of the 62 ancestors have a recall of any class.
- Of its descendants, K100724 (Biomet 3i, Inc., 2011) has gone furthest, with 27 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. 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?
BIOMET 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 utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
BIOMET 3i Osseotite and NanoTite dental implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062636: Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP, Microminiplant, Dental Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062636
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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