510(k) · Cleared
Cleared3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615
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 Nov 7, 2003 as substantially equivalent to K972444 (Implant Innovations, Inc., 1997) and 1 other predicate after a 10-day review. Its family tree reaches back 5 generations to 1993. 213 later devices descend from it.
- Decided
- Nov 7, 2003
- Review
- 10 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K925765 (1993). 12 ancestors in all, the oldest K874590 (1988). 213 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 4 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 3 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 2 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 1 generation backK031632 Osseotite Iol Implants and Osseotite Certain Iol ImplantsImplant Innovations, Inc. · 2003
- This deviceK033430 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685…Implant Innovations, Inc. · 2003
- Descendant · cites it directly · 211 of its ownK063286 Osseotite; Osseotite NT; XP; TG OsseotiteImplant 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 · 2 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 3 generations on · 42 of its ownK150295 LOCATOR RTxZest Anchors, Inc. · 2015
Showing 5 of 213 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 213 · See all- K063286Osseotite; Osseotite NT; XP; TG OsseotiteImplant Innovations, Inc. · 2007 · cites it directly211descendants
- K120414Osseospeed PlusAstra Tech AB · 2012 · 2 generations on196descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 2 generations on51descendants
- K150295LOCATOR RTxZest Anchors, Inc. · 2015 · 3 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −4 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −3 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −2 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −1 | K031632 | Osseotite Iol Implants and Osseotite Certain Iol Implants | Implant Innovations, Inc. | 2003 | — |
| 0 (this device) | K033430 | 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610… | Implant Innovations, Inc. | 2003 | — |
| +1 | K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | Implant Innovations, Inc. | 2007 | 5 |
| +2 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +2 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +3 | K150295 | LOCATOR RTx | Zest Anchors, Inc. | 2015 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K972444 | 3I Innovative Implants and Cover ScrewsSummary page 1…Dental Devices Panel 21 CFR tj 872.3640 Predicate TG OSSEOTITE@Dental Implants Devices IC972444 OSSEOTITE* IOL Implants KO3 1632 Performance P… | 1997 |
| * | K031632 | Osseotite Iol Implants and Osseotite Certain Iol Implants | 2003 |
What descends from it? (213)
See all 2132 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 10 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K063286 (Implant Innovations, Inc., 2007) has gone furthest, with 211 descendants of its own.
- 7 other devices also cite its predicate K972444.
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/K033430 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033430: 3I TG Osseotite Implant, Models TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033430
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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