510(k) · Cleared
Recalled · Class II · 2018Zimmer Dental Tapered Screw-Vent M Implant
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 Dec 6, 2011 after a 158-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled once.
- Decided
- Dec 6, 2011
- Review
- 158 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK111889 Zimmer Dental Tapered Screw-Vent M ImplantZimmer Dental, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK133339 Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental…Zimmer Dental, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK143051 ArgenIS Titanium AbutmentsThe Argen Corporation · 2015
- Descendant · 3 generations on · 1 of its ownK160248 ArgenIS Titanium AbutmentsArgen Corporation · 2016
- Descendant · cites it directly · 0 of its ownK243731 HEXIM Implant; Samwon General AbutmentsP&A USA · 2025
- Descendant · 4 generations on · 0 of its ownK172430 ArgenIS Titanium AbutmentsArgen Corporation · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133339Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M…Zimmer Dental, Inc. · 2014 · cites it directly3descendants
- K143051ArgenIS Titanium AbutmentsThe Argen Corporation · 2015 · 2 generations on2descendants
- K160248ArgenIS Titanium AbutmentsArgen Corporation · 2016 · 3 generations on1descendant
- K243731HEXIM Implant; Samwon General AbutmentsP&A USA · 2025 · cites it directly0descendants
- K172430ArgenIS Titanium AbutmentsArgen Corporation · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111889 | Zimmer Dental Tapered Screw-Vent M Implant | Zimmer Dental, Inc. | 2011 | — |
| +1 | K133339 | Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered… | Zimmer Dental, Inc. | 2014 | — |
| +2 | K143051 | ArgenIS Titanium Abutments | The Argen Corporation | 2015 | — |
| +3 | K160248 | ArgenIS Titanium Abutments | Argen Corporation | 2016 | — |
| +1 | K243731 | HEXIM Implant; Samwon General Abutments | P&A USA | 2025 | — |
| +4 | K172430 | ArgenIS Titanium Abutments | Argen Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | — | Tapered Screw-Vent® T Implant Named without a submission number | |
| * | — | Tapered Screw-Vent® Implant System Named without a submission number | |
| † | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… | 2006 |
What descends from it? (6)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2018 | Class II | Z-2963-2018 | Labeling mix-ups | Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K133339 (Zimmer Dental, Inc., 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Tapered Screw-Vent® M 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111889: Zimmer Dental Tapered Screw-Vent M Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111889
Report an extraction error
Are you the manufacturer?
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