510(k) · Cleared
ClearedZimmer Dental Tapered Screw-Vent X
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 Aug 30, 2012 as substantially equivalent to K101880 (Zimmer Dental, Inc., 2010) and 5 other predicates after a 253-day review. Its family tree reaches back 9 generations to 1990. 1 later device descends from it.
- Decided
- Aug 30, 2012
- Review
- 253 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K894595 (1990). 35 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062566 Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC · 2006 · Recalled
- 1 generation backK101880 Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc. · 2010 · Recalled
- This deviceK113753 Zimmer Dental Tapered Screw-Vent XZimmer Dental, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK132258 Zimmer Dental Trabecular Metal Implant SystemZimmer Dental, Inc. · 2013
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 2 generations backK062566 Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC · 2006 · Recalled
- 1 generation backK101880 Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc. · 2010 · Recalled
- This deviceK113753 Zimmer Dental Tapered Screw-Vent XZimmer Dental, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K132258Zimmer Dental Trabecular Metal Implant SystemZimmer Dental, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −6 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −5 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −2 | K062566 | Nobelreplace Tapered Conical Connection | Nobel Biocare USA, LLC | 2006 | 27 |
| −1 | K101880 | Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant | Zimmer Dental, Inc. | 2010 | 1 |
| 0 (this device) | K113753 | Zimmer Dental Tapered Screw-Vent X | Zimmer Dental, Inc. | 2012 | — |
| +1 | K132258 | Zimmer Dental Trabecular Metal Implant System | Zimmer Dental, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (6)
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 |
|---|---|---|---|
| * | K101880 | Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantSummary page 1…cate Device(s): Predicate Device No. 1 Trade Name: Zimmer Dental Tapered Screw-Vent®D P Implant 510(k) Number: K101880 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name:… | 2010 |
| * | K011028 | Screw-Vent Dental Implant SystemSummary page 1…. 2 Trade Name: Zimmer Dental Tapered Screw-Vent® Implant System 510(k) Number K011028 / K953101 / K013227 / K061410I K072589 Regulation Number: 872.3640… | 2001 |
| * | K953101 | Paragon Implant SystemSummary page 1…Trade Name: Zimmer Dental Tapered Screw-Vent® Implant System 510(k) Number K011028 / K953101 / K013227 / K061410I K072589 Regulation Number: 872.3640 Cla… | 1995 |
| * | K013227 | Screw Vent Implant; Tapered Screw Vent ImplantSummary page 1…Name: Zimmer Dental Tapered Screw-Vent® Implant System 510(k) Number K011028 / K953101 / K013227 / K061410I K072589 Regulation Number: 872.3640 Classificatio… | 2001 |
| * | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Summary page 1…Zimmer Dental Tapered Screw-Vent® Implant System 510(k) Number K011028 / K953101 / K013227 / K061410I K072589 Regulation Number: 872.3640 Classification Code:… | 2006 |
| * | K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11…Summary page 1…plant System 510(k) Number K011028 / K953101 / K013227 / K061410I K072589 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name:… | 2007 |
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 |
|---|---|---|---|
| K132258 | Zimmer Dental Trabecular Metal Implant System | 2013 | 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 22 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 35 ancestors have a recall of any class.
- Of its descendants, K132258 (Zimmer Dental, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K101880.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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® X 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. The 4.1mmD Tapered Screw Vent X Implants should be splinted to additional implants when used in the posterior region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113753 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113753: Zimmer Dental Tapered Screw-Vent X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113753
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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