510(k) · Cleared
Cleared3I Osseotite 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 Sep 15, 2005 as substantially equivalent to K014235 (Implant Innovations, Inc., 2002) and 11 other predicates after a 104-day review. Its family tree reaches back 7 generations to 1993. 312 later devices descend from it.
- Decided
- Sep 15, 2005
- Review
- 104 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 7 generations to K925765 (1993). 60 ancestors in all, the oldest K781060 (1978). 312 later devices descend from it, 7 citing it directly.
- Root · 7 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 6 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 5 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 4 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 3 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 2 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 1 generation backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- This deviceK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
- Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · cites it directly · 59 of its ownK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
Showing 5 of 312 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 312 · See all- K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · cites it directly211descendants
- K0633413I Osseotite Certain Dental ImplantsImplant Innovations, Inc. · 2007 · cites it directly209descendants
- K120414Osseospeed PlusAstra Tech AB · 2012 · 2 generations on196descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
- K062432Nanotite Dental ImplantsImplant Innovations, Inc. · 2007 · cites it directly59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −6 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −5 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −4 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −3 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −2 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −1 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| 0 (this device) | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| +1 | K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | Implant Innovations, Inc. | 2007 | 5 |
| +1 | K063341 | 3I Osseotite Certain Dental Implants | Implant Innovations, Inc. | 2007 | 10 |
| +2 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +1 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
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 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 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? (12)
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 K(014235 - OSSEOTITE NTTm Dental Implants Devices K972444 - 3i Innovative Implants and Cover Screws… | 2002 |
| * | K972444 | 3I Innovative Implants and Cover ScrewsSummary page 1…evices Panel 21 CFR § 872.3640 Predicate K(014235 - OSSEOTITE NTTm Dental 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…K(014235 - OSSEOTITE NTTm Dental 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 K9S3347 - OSSEOTITE, Dental Implants… | 1998 |
| * | K983347 | Osseotite Dental Implants Our reading of the summary gave K953347, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “OSSEOTITE Dental Implants”. | 1999 |
| * | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsSummary page 1…K980549 - OSSEOTITE Dental Implants K9S3347 - OSSEOTITE, Dental Implants K022009 - 3i Dental Implants K955428 - Hydroxylapatite (H-A) Coated Endosseous… | 2002 |
| * | K955428 | 3I Hydroxylapatite Coated Standard Threaded & Self-Tapping ImplantsSummary page 1…mplants K9S3347 - OSSEOTITE, Dental Implants K022009 - 3i Dental Implants K955428 - Hydroxylapatite (H-A) Coated Endosseous Implants K(0… | 1996 |
| * | K031475 | Osseotite NT Certain ImplantsSummary page 1…s K955428 - Hydroxylapatite (H-A) Coated Endosseous Implants K(031475 - 3i OSSEOTITE NT Certain Implants K030614 - 3i Implants K03 163… | 2003 |
| * | K030614 | 3I Dental ImplantsSummary page 1…dosseous Implants K(031475 - 3i OSSEOTITE NT Certain Implants K030614 - 3i Implants K03 1632 - 3i IOL Implants 1(041402 - OSSEOTITE NT… | 2003 |
| * | K031632 | Osseotite Iol Implants and Osseotite Certain Iol ImplantsSummary page 1…plants K(031475 - 3i OSSEOTITE NT Certain Implants K030614 - 3i Implants K03 1632 - 3i IOL Implants 1(041402 - OSSEOTITE NT Certain Implants K(0511… | 2003 |
| * | K041402 | Modification to Osseotite NT Certain ImplantsSummary page 1…TE NT Certain Implants K030614 - 3i Implants K03 1632 - 3i IOL Implants 1(041402 - OSSEOTITE NT Certain Implants K(051189 -Prevail Implants Implant Innovations, I… | 2004 |
| * | K051189 | Prevail Dental Implants Cleared while this submission was under review Summary page 1…nts K03 1632 - 3i IOL Implants 1(041402 - OSSEOTITE NT Certain Implants K(051189 -Prevail Implants Implant Innovations, Inc. 510(k) Premarket Notification - A Modification to 3i OSSEOTITF.~ Dent… | 2005 |
What descends from it? (312)
See all 3127 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | 2007 | 211 |
| K063341 | 3I Osseotite Certain Dental Implants | 2007 | 209 |
| K062432 | Nanotite Dental Implants | 2007 | 59 |
| K072363 | Nanotite Prevail,Certain,Parellel Walled,Tapered,External Hex | 2008 | 35 |
| K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | 2007 | 28 |
| K122300 | T3 Dental Implant | 2013 | 22 |
| K073458 | BT-Tite One (BTICV1), BT-Tite Standard (Btivsm), BT-Tite CV2(BTICV2) | 2008 | 2 |
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 12 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 8 of the 60 ancestors have a recall of any class.
- Of its descendants, K063286 (Implant Innovations, Inc., 2007) has gone furthest, with 211 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 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, > 10 mm 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/K051461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051461: 3I Osseotite 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/K051461
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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