510(k) · Cleared
Recalled · Class II · 2017Osseotite; Osseotite NT; XP; TG Osseotite
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 Apr 24, 2007 as substantially equivalent to K874590 (Implant Innovations International, Inc., 1988) and 9 other predicates after a 175-day review. Its family tree reaches back 8 generations to 1993. 211 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 24, 2007
- Review
- 175 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 5
- Predicates
- 11
Its longest line of descent runs back 8 generations to K925765 (1993). 62 ancestors in all, the oldest K781060 (1978). 211 later devices descend from it, 10 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 deviceK063286 Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007
- Descendant · cites it directly · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
- Descendant · cites it directly · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · cites it directly · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 2 generations on · 42 of its ownK150295 LOCATOR RTxZest Anchors, Inc. · 2015
- Descendant · 2 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
Showing 5 of 211 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 211 · See all- K120414Osseospeed PlusAstra Tech AB · 2012 · cites it directly196descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · cites it directly86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · cites it directly51descendants
- K150295LOCATOR RTxZest Anchors, Inc. · 2015 · 2 generations on42descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 2 generations on38descendants
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) | K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | Implant Innovations, Inc. | 2007 | — |
| +1 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +1 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +1 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +2 | K150295 | LOCATOR RTx | Zest Anchors, Inc. | 2015 | — |
| +2 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
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 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 8 | 0 |
| 2019 | 10 | 0 |
| 2020 | 14 | 0 |
| 2021 | 14 | 0 |
| 2022 | 22 | 0 |
| 2023 | 27 | 0 |
| 2024 | 31 | 0 |
| 2025 | 34 | 0 |
| 2026 | 17 | 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? (11)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K874590 | Innovative Implants and Cover ScrewsSummary page 1…Dental Devices Panel 21 CFR § 872.3640 Predicate 3i OSSEOTII'E Dental Implants Devices K874590, K935544, K972444. K980549. K983347. K992334, K014235, K022009,… | 1988 |
| * | K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants ModificationSummary page 1…ntal Devices Panel 21 CFR § 872.3640 Predicate 3i OSSEOTII'E Dental Implants Devices K874590, K935544, K972444. K980549. K983347. K992334, K014235, K022009, K03016… | 1995 |
| * | K972444 | 3I Innovative Implants and Cover ScrewsSummary page 1…ces Panel 21 CFR § 872.3640 Predicate 3i OSSEOTII'E Dental Implants Devices K874590, K935544, K972444. K980549. K983347. K992334, K014235, K022009, K030164,… | 1997 |
| * | K980549 | Osseotite Dental Implant SystemSummary page 1…21 CFR § 872.3640 Predicate 3i OSSEOTII'E Dental Implants Devices K874590, K935544, K972444. K980549. K983347. K992334, K014235, K022009, K030164,… | 1998 |
| * | K983347 | Osseotite Dental ImplantsSummary page 1…21 CFR § 872.3640 Predicate 3i OSSEOTII'E Dental Implants Devices K874590, K935544, K972444. K980549. K983347. K992334, K014235, K022009, K030164, K033430… | 1999 |
| * | K992334 | Endosseous Implants and Abutments- Tin CoatingSummary page 1…3i OSSEOTII'E Dental Implants Devices K874590, K935544, K972444. K980549. K983347. K992334, K014235, K022009, K030164, K033430, K051461 Performance… | 1999 |
| * | K014235 | Osseotite NT Dental Implants & AccessoriesSummary page 1…3i OSSEOTII'E Dental Implants Devices K874590, K935544, K972444. K980549. K983347. K992334, K014235, K022009, K030164, K033430, K051461 Performance Performance… | 2002 |
| * | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsSummary page 1…TII'E Dental Implants Devices K874590, K935544, K972444. K980549. K983347. K992334, K014235, K022009, K030164, K033430, K051461 Performance Performance standards hav… | 2002 |
| Kept off the family tree | K030164 | FDA’s K030164 is Non-Sterile, Powder-Free, Polymer Coated, Natural and/or Violet and Black… Our reading of the summary gave K030164, FDA’s number for Non-Sterile, Powder-Free, Polymer Coated, Natural and/or… (Yty Industry (Manjung) Sdn Bhd). Its FDA name has none of the distinctive words the summary uses for the device it names, “3i OSSEOTITE Dental Implants”. Kept off the family tree. Summary page 1…evices K874590, K935544, K972444. K980549. K983347. K992334, K014235, K022009, K030164, K033430, K051461 Performance Performance standards have not been established… | 2003 |
| * | K033430 | 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611…Summary page 1…935544, K972444. K980549. K983347. K992334, K014235, K022009, K030164, K033430, K051461 Performance Performance standards have not been established by the FD… | 2003 |
| * | K051461 | 3I Osseotite Dental ImplantsSummary page 1…972444. K980549. K983347. K992334, K014235, K022009, K030164, K033430, K051461 Performance Performance standards have not been established by the FDA under S… | 2005 |
What descends from it? (211)
See all 21110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120414 | Osseospeed Plus | 2012 | 196 |
| K170588 | DESS Dental Smart Solutions | 2017 | 86 |
| K173908 | DESS Dental Smart Solutions | 2018 | 51 |
| K100724 | Osseotite II Model Xifossxxx | 2011 | 27 |
| K111216 | Osseotite 2 Dental Implants | 2011 | 21 |
| K133049 | 3I T3(R) External Hex Dental Implants | 2014 | 19 |
| K142167 | Medentika Abutment System | 2015 | 7 |
| K142426 | EBI External Implant System | 2015 | 0 |
| K133733 | WINSIX Implant System | 2015 | 0 |
| K073622 | Easy Grip Dental Implant System | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 8, 2017 | Class II | Z-1701-2017 | Under Investigation by firm | A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier |
| Nov 25, 2015 | Class II | Z-2458-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2469-2016 | Packaging | Pouches may not have been sealed during packing. |
| Nov 25, 2015 | Class II | Z-2457-2016 | Packaging | Pouches may not have been sealed during packing. |
| Aug 3, 2007 | Not classified | Z-1221-2007 | Labeling mix-ups | The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants. |
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 62 ancestors have a recall of any class.
- Of its descendants, K120414 (Astra Tech AB, 2012) has gone furthest, with 196 descendants of its own.
- 8 other devices also cite its predicate K874590.
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 lowerjaw 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 mandible and splinted in the anterior region, immediate loading is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063286 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063286: Osseotite; Osseotite NT; XP; TG Osseotite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063286
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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