510(k) · Cleared
ClearedTSX 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 Sep 14, 2022 as substantially equivalent to K072589 (Zimmer Dental, Inc., 2007) after a 163-day review. Its family tree reaches back 8 generations to 1990. 1 later device descends from it.
- Decided
- Sep 14, 2022
- Review
- 163 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K894595 (1990). 28 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 4 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 3 generations backK050705 Tiunite ImplantsNobel Biocare AB · 2005 · Recalled
- 2 generations backK061410 Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System…Zimmer Dental, Inc. · 2006 · Recalled
- 1 generation backK072589 Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and…Zimmer Dental, Inc. · 2007 · Recalled
- This deviceK220978 TSX ImplantsBiomet 3i, LLC · 2022
- Descendant · cites it directly · 0 of its ownK241753 Immediate Molar ImplantsBiomet 3i, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K241753Immediate Molar ImplantsBiomet 3i, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −4 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −3 | K050705 | Tiunite Implants | Nobel Biocare AB | 2005 | 1 |
| −2 | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent… | Zimmer Dental, Inc. | 2006 | 1 |
| −1 | K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16… | Zimmer Dental, Inc. | 2007 | 3 |
| 0 (this device) | K220978 | TSX Implants | Biomet 3i, LLC | 2022 | — |
| +1 | K241753 | Immediate Molar Implants | Biomet 3i, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11…Summary page 4…. Predicate Devices: Primary predicate device: • Trade Name: Tapered Screw-Vent Implant, 4.1mmD • 510(k): K072589 • Regulation Number: 21 CFR 872.3640 • Product Code: DZE • SE Date:… | 2007 |
| † | K142082 | Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour Abutement | 2014 |
| † | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | 2001 |
| † | K122300 | T3 Dental Implant | 2013 |
| † | K150571 | 3i T3 Short Implants | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241753 | Immediate Molar Implants | 2024 | 0 |
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 32 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 28 ancestors have a recall of any class.
- Of its descendants, K241753 (Biomet 3i, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K072589.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The TSX Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical) and provide good primary stability.
The 3.1mmD TSX Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220978: TSX Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220978
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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