510(k) · Cleared
ClearedImmediate Molar Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet 3i, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Oct 23, 2024 as substantially equivalent to K213672 (Biomet 3i, LLC, 2022) and 2 other predicates after a 127-day review. Its family tree reaches back 14 generations to 1993.
- Decided
- Oct 23, 2024
- Review
- 127 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K925765 (1993). 93 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 14 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 10 generations between
- 3 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 2 generations backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- 1 generation backK150571 3i T3 Short ImplantsBiomet 3i · 2015
- This deviceK241753 Immediate Molar ImplantsBiomet 3i, LLC · 2024
Show all 14 generations
- Root · 14 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 13 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 12 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 11 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 10 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 9 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 8 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 7 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 6 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 5 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 4 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 3 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 2 generations backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- 1 generation backK150571 3i T3 Short ImplantsBiomet 3i · 2015
- This deviceK241753 Immediate Molar ImplantsBiomet 3i, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −13 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −12 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −11 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −10 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −9 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −8 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −7 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −6 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| −5 | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| −4 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| −3 | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| −2 | K133049 | 3I T3(R) External Hex Dental Implants | Biomet 3i | 2014 | — |
| −1 | K150571 | 3i T3 Short Implants | Biomet 3i | 2015 | — |
| 0 (this device) | K241753 | Immediate Molar Implants | Biomet 3i, LLC | 2024 | — |
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 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K213672 | T3 Pro ImplantsSummary page 5…tory Class: Class II V. Product Code: DZE VI. Predicate Devices: Primary Predicate Device: • T3 PRO Implants (K213672) Reference Predicate Devices: • TSX Implants (K220978) • Tapered Screw Vent Implants (K013227)… | 2022 |
| * | K220978 | TSX ImplantsSummary page 5…DZE VI. Predicate Devices: Primary Predicate Device: • T3 PRO Implants (K213672) Reference Predicate Devices: • TSX Implants (K220978) • Tapered Screw Vent Implants (K013227) • 3i T3 Short Dental Implants (K150571) • Implanova (K2… | 2022 |
| * | K150571 | 3i T3 Short ImplantsSummary page 5…72) Reference Predicate Devices: • TSX Implants (K220978) • Tapered Screw Vent Implants (K013227) • 3i T3 Short Dental Implants (K150571) • Implanova (K210523) • Southern Implants MAX Implant System (K191054) VII. Product Description:… | 2015 |
| † | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | 2001 |
| † | K210523 | Implanova | 2021 |
| † | K191054 | Southern Implants MAX Implant System | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 18 of the 93 ancestors have a recall of any class.
- 1 other device also cites its predicate K213672.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Immediate Molar 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 loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. Immediate Molar Dental Implants may also utilize immediate loading for these…
Read the full statement (225 words)
Immediate Molar 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 loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.
Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar 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. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.
The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems:
Abutment System Name Models Platform Diameters
Abutments manufactured by
Terrats Medical SL Titanium Abutments 4.1, 5.0 and 5.7mm
Abutments manufactured by
Zfx GmbH Titanium Abutments 4.1, 5.0 and 5.7mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241753 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241753: Immediate Molar Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241753
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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