510(k) · Cleared
Recalled · Class II · 2016Tapered Screw-Vent X 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 14, 2011 as substantially equivalent to K101880 (Zimmer Dental, Inc., 2010) and 5 other predicates after a 140-day review. Its family tree reaches back 9 generations to 1990. 88 later devices descend from it. It has been recalled 19 times.
- Decided
- Dec 14, 2011
- Review
- 140 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 19
- Predicates
- 6
Its longest line of descent runs back 9 generations to K894595 (1990). 35 ancestors in all. 88 later devices descend from it, 3 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 deviceK112160 Tapered Screw-Vent X ImplantZimmer Dental, Inc. · 2011
- Descendant · cites it directly · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · cites it directly · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 2 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- Descendant · 2 generations on · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- Descendant · 2 generations on · 20 of its ownK212628 DESS Dental Smart SolutionsTerrats Medical SL · 2022
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 deviceK112160 Tapered Screw-Vent X ImplantZimmer Dental, Inc. · 2011
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
2013high 21 (2025) · low 0 (2014)2026
Most influential descendants
Showing 5 of 88 · See all- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · cites it directly86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · cites it directly51descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 2 generations on38descendants
- K183518Preat AbutmentsPreat Corporation · 2019 · 2 generations on22descendants
- K212628DESS Dental Smart SolutionsTerrats Medical SL · 2022 · 2 generations on20descendants
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) | K112160 | Tapered Screw-Vent X Implant | Zimmer Dental, Inc. | 2011 | — |
| +1 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +1 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +2 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| +2 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| +2 | K212628 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
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 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 10 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 21 | 0 |
| 2026 | 11 | 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…redicate Device(s): Predicate Device No. 1 Trade Name: Zimmer Dental Tapered Screw-Vent® P Implant 510(k) Number: K101880 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: En… | 2010 |
| * | K011028 | Screw-Vent Dental Implant SystemSummary page 1…No. 2 Trade Name: Zimmer Dental Tapered Screw-Vent® Implant System 510(k) Number: K01 1028 /K953101 / K013227 /K061410/ K072589 Regulation Number: 872.3640… | 2001 |
| * | K953101 | Paragon Implant SystemSummary page 1…Trade Name: Zimmer Dental Tapered Screw-Vent® Implant System 510(k) Number: K01 1028 /K953101 / K013227 /K061410/ K072589 Regulation Number: 872.3640 Classifi… | 1995 |
| * | K013227 | Screw Vent Implant; Tapered Screw Vent ImplantSummary page 1…de Name: Zimmer Dental Tapered Screw-Vent® Implant System 510(k) Number: K01 1028 /K953101 / K013227 /K061410/ K072589 Regulation Number: 872.3640 Classification Cod… | 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: K01 1028 /K953101 / K013227 /K061410/ K072589 Regulation Number: 872.3640 Classification Code: D… | 2006 |
| * | K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11…Summary page 1…t® Implant System 510(k) Number: K01 1028 /K953101 / K013227 /K061410/ K072589 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name: En… | 2007 |
What descends from it? (88)
See all 883 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 |
|---|---|---|---|---|
| Jan 6, 2016 | Class II | Z-0775-2016 | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. |
| Jan 6, 2016 | Class II | Z-0772-2016 | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. |
| Jan 6, 2016 | Class II | Z-0774-2016 | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. |
| Jan 6, 2016 | Class II | Z-0783-2016 | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. |
| Jan 6, 2016 | Class II | Z-0784-2016 | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. |
| Jan 6, 2016 | Class II | Z-0773-2016 | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. |
| Jan 6, 2016 | Class II | Z-0780-2016 | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. |
| Jan 6, 2016 | Class II | Z-0776-2016 | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. |
| Jan 6, 2016 | Class II | Z-0777-2016 | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. |
| Jan 6, 2016 | Class II | Z-0778-2016 | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. |
| Jan 6, 2016 | Class II | Z-0779-2016 | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. |
| Jan 6, 2016 | Class II | Z-0781-2016 | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. |
| Jan 6, 2016 | Class II | Z-0782-2016 | Labeling Change Control | Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections. |
| Mar 22, 2012 | Not classified | Z-1511-2012 | Labeling Change Control | This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient… |
| Mar 22, 2012 | Not classified | Z-1510-2012 | Labeling Change Control | This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient… |
| Mar 22, 2012 | Not classified | Z-1514-2012 | Labeling Change Control | This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient… |
| Mar 22, 2012 | Not classified | Z-1512-2012 | Labeling Change Control | This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient… |
| Mar 22, 2012 | Not classified | Z-1515-2012 | Labeling Change Control | This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient… |
| Mar 22, 2012 | Not classified | Z-1513-2012 | Labeling Change Control | This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient… |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 35 ancestors have a recall of any class.
- Of its descendants, K170588 (Terrats Medical SL, 2017) has gone furthest, with 86 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. 2011, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2007high 61 (2008) · low 26 (2011)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
2007high 265 (2014) · low 107 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
2007high 15 (2016) · low 0 (2011)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
2007high 537,585 (2023) · low 164 (2009)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/K112160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112160: Tapered Screw-Vent X Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112160
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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