510(k) · Cleared
Cleared3I T3(R) External Hex Dental Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet 3i · DZE Implant, Endosseous, Root-Form
Cleared on Jan 8, 2014 as substantially equivalent to K122300 (Biomet 3i, 2013) and 2 other predicates after a 103-day review. Its family tree reaches back 12 generations to 1993. 19 later devices descend from it.
- Decided
- Jan 8, 2014
- Review
- 103 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K925765 (1993). 69 ancestors in all, the oldest K781060 (1978). 19 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 8 generations between
- 3 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 2 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 1 generation backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- This deviceK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- Descendant · cites it directly · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 3 of its ownK193084 TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · 2 generations on · 2 of its ownK180465 Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK231967 ARi ExCon Implant SystemMegagen Implant Co., Ltd. · 2023
Show all 12 generations
- Root · 12 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 11 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 10 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 9 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 8 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 7 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 6 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 5 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 4 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 3 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 2 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 1 generation backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- This deviceK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · cites it directly13descendants
- K193084TIB Abutment SystemSouthern Implants (Pty), Ltd. · 2020 · 2 generations on3descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 2 generations on2descendants
- K180465Provata Implant SystemSouthern Implants (Pty), Ltd. · 2018 · 2 generations on2descendants
- K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −11 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −10 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −9 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −8 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −7 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −6 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −5 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −4 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| −3 | 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 |
| −1 | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| 0 (this device) | K133049 | 3I T3(R) External Hex Dental Implants | Biomet 3i | 2014 | — |
| +1 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| +2 | K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | 2020 | — |
| +2 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +2 | K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | 2018 | — |
| +2 | K231967 | ARi ExCon Implant System | Megagen Implant Co., Ltd. | 2023 | — |
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 |
| 2007 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K122300 | T3 Dental ImplantSummary page 1…implant options for connection to existing Biomet 3iTM external hex restorative components. The primary change from the predicate 3i T310 devices in K122300 is that the connection geometry is an external connection instead of an internal… | 2013 |
| * | K111216 | Osseotite 2 Dental Implants | 2011 |
| * | K063286 | Osseotite; Osseotite NT; XP; TG OsseotiteSummary page 2…" 3i T31® Dental Implants (K122300) " OSSEOTITEO 2 External Hex Parallel Walled Dental Implants (KI 11216) " OSSEOTITE® External Hex Dental Implants (K063286) XI. Discussion of the Non-Clinical Testing Non-clinical testing in the form of mfechanical testing was performed on t… | 2007 |
What descends from it? (19)
See all 194 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 21 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 12 of the 69 ancestors have a recall of any class.
- Of its descendants, K163634 (Southern Implants (Pty), Ltd., 2017) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K122300.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 T3® 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.
3i T3® 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/K133049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133049: 3I T3(R) External Hex 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/K133049
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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