510(k) · Cleared
ClearedZimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M Implant, HA Coated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Dental, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Mar 4, 2014 as substantially equivalent to K013227 (Sulzer Dental, Inc., 2001) and 3 other predicates after a 125-day review. Its family tree reaches back 7 generations to 1990. 3 later devices descend from it.
- Decided
- Mar 4, 2014
- Review
- 125 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K894595 (1990). 29 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 4 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 3 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 2 generations backK050705 Tiunite ImplantsNobel Biocare AB · 2005 · Recalled
- 1 generation backK061410 Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System…Zimmer Dental, Inc. · 2006 · Recalled
- This deviceK133339 Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental…Zimmer Dental, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK143051 ArgenIS Titanium AbutmentsThe Argen Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK160248 ArgenIS Titanium AbutmentsArgen Corporation · 2016
- Descendant · 3 generations on · 0 of its ownK172430 ArgenIS Titanium AbutmentsArgen Corporation · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −4 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −3 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −2 | K050705 | Tiunite Implants | Nobel Biocare AB | 2005 | 1 |
| −1 | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent… | Zimmer Dental, Inc. | 2006 | 1 |
| 0 (this device) | K133339 | Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered… | Zimmer Dental, Inc. | 2014 | — |
| +1 | K143051 | ArgenIS Titanium Abutments | The Argen Corporation | 2015 | — |
| +2 | K160248 | ArgenIS Titanium Abutments | Argen Corporation | 2016 | — |
| +3 | K172430 | ArgenIS Titanium Abutments | Argen Corporation | 2018 | — |
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 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K013227 | Screw Vent Implant; Tapered Screw Vent ImplantSummary page 1…Name: Zimmer Dental Tapered Screw Vent® Implant, HA Coated 5 10(k): KO013227, K06141 0 Classification Code: DZE Device Classification Name: Implant, Endosseous, Root-Form… | 2001 |
| * | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Summary page 1…Zimmer Dental Tapered Screw Vent® Implant, HA Coated 5 10(k): KO013227, K06141 0 Classification Code: DZE Device Classification Name: Implant, Endosseous, Root-Form Pred… | 2006 |
| * | K101977 | Tapered Screw-Vent T ImplantSummary page 1…mmer Dental Tapered Screw Vent® T Implant Zimmer Dental Tapered Screw Vent® M Implant 510(k): K10 1977, K111889 Classification Code: OZE Device Classification Name: Implant, Endosseous, Root-Form… | 2010 |
| * | K111889 | Zimmer Dental Tapered Screw-Vent M ImplantSummary page 1…l Tapered Screw Vent® T Implant Zimmer Dental Tapered Screw Vent® M Implant 510(k): K10 1977, K111889 Classification Code: OZE Device Classification Name: Implant, Endosseous, Root-Form === Page… | 2011 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143051 | ArgenIS Titanium Abutments | 2015 | 2 |
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 24 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 29 ancestors have a recall of any class.
- Of its descendants, K143051 (The Argen Corporation, 2015) has gone furthest, with 2 descendants of its own.
- 14 other devices also cite its predicate K013227.
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?
The Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133339 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133339: Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M Implant, HA Coated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133339
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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