510(k) · Cleared
Recalled · 2009Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant System,AV;Zimmer One-Piece 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 Sep 8, 2006 as substantially equivalent to K013227 (Sulzer Dental, Inc., 2001) and 5 other predicates after a 109-day review. Its family tree reaches back 6 generations to 1990. 122 later devices descend from it. It has been recalled once.
- Decided
- Sep 8, 2006
- Review
- 109 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 6 generations to K894595 (1990). 26 ancestors in all. 122 later devices descend from it, 13 citing it directly.
- Root · 6 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 4 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 3 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 2 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 1 generation backK050705 Tiunite ImplantsNobel Biocare AB · 2005 · Recalled
- This deviceK061410 Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System…Zimmer Dental, Inc. · 2006
- Descendant · cites it directly · 98 of its ownK072589 Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and…Zimmer Dental, Inc. · 2007 · Recalled
- Descendant · cites it directly · 94 of its ownK101880 Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc. · 2010 · Recalled
- Descendant · cites it directly · 88 of its ownK112160 Tapered Screw-Vent X ImplantZimmer Dental, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 2 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
Showing 5 of 122 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 122 · See all- K072589Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11…Zimmer Dental, Inc. · 2007 · cites it directly98descendants
- K101880Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc. · 2010 · cites it directly94descendants
- K112160Tapered Screw-Vent X ImplantZimmer Dental, Inc. · 2011 · cites it directly88descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 2 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −5 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −4 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −3 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −2 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −1 | K050705 | Tiunite Implants | Nobel Biocare AB | 2005 | 1 |
| 0 (this device) | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent… | Zimmer Dental, Inc. | 2006 | — |
| +1 | K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16… | Zimmer Dental, Inc. | 2007 | 3 |
| +1 | K101880 | Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant | Zimmer Dental, Inc. | 2010 | 1 |
| +1 | K112160 | Tapered Screw-Vent X Implant | Zimmer Dental, Inc. | 2011 | 19 |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +2 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 0 |
| 2022 | 12 | 0 |
| 2023 | 16 | 0 |
| 2024 | 16 | 0 |
| 2025 | 23 | 0 |
| 2026 | 12 | 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 |
|---|---|---|---|
| * | K013227 | Screw Vent Implant; Tapered Screw Vent ImplantSummary page 2…e of this submission is to add an immediate loading single tooth indication to the following implants systems previously cleared by FDA: Tapered Screw-Vent, Screw- Vent (K013227), AdVent (KO0 1245) and Zimmer One-Piece 3.7 mm (K052997). These implants are titanium alloy, self-tapping implants that incorpor… | 2001 |
| * | K950577 | Swede-Vent ImplantSummary page 2…ications and design principles to predicate devices previously cleared for marketing by FDA: Zimmer Dental Tapered Screw- Vent Implants and Screw-Vent Implants (K013227, K950577), Zimmer Dental AdVent Implants (KO I1245, K002614), Zimmer One-Piece 3.7 mm Implant (K052997); and the Nobel Biocare TiUnite Den… | 1995 |
| * | K011245 | Advent Implant System, Swiss Plus Implant System Our reading of the summary gave K001245, FDA’s number for 3T L. V. Control Valve (3t Medical Systems, LLC). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Zimmer Dental AdVent Implants”. | 2001 |
| * | K002614 | Advent Implant SystemSummary page 2…previously cleared for marketing by FDA: Zimmer Dental Tapered Screw- Vent Implants and Screw-Vent Implants (K013227, K950577), Zimmer Dental AdVent Implants (KO I1245, K002614), Zimmer One-Piece 3.7 mm Implant (K052997); and the Nobel Biocare TiUnite Dental Implants (K050705). Zimmer Dental Implants - I… | 2000 |
| * | K052997 | Zimmer Dental One-Piece ImplantSummary page 2…e tooth indication to the following implants systems previously cleared by FDA: Tapered Screw-Vent, Screw- Vent (K013227), AdVent (KO0 1245) and Zimmer One-Piece 3.7 mm (K052997). These implants are titanium alloy, self-tapping implants that incorporate either the MTX or MP- I surface. There is no signific… | 2006 |
| * | K050705 | Tiunite ImplantsSummary page 2…Implants (K013227, K950577), Zimmer Dental AdVent Implants (KO I1245, K002614), Zimmer One-Piece 3.7 mm Implant (K052997); and the Nobel Biocare TiUnite Dental Implants (K050705). Zimmer Dental Implants - Immediate Loading Indication have the following similarities to the predicate devices: * have… | 2005 |
What descends from it? (122)
See all 12213 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11… | 2007 | 98 |
| K101880 | Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant | 2010 | 94 |
| K112160 | Tapered Screw-Vent X Implant | 2011 | 88 |
| K142167 | Medentika Abutment System | 2015 | 7 |
| K110577 | Osseofuse Dental Implant System | 2011 | 4 |
| K133339 | Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M… | 2014 | 3 |
| K102822 | Implant-One System | 2011 | 3 |
| K213576 | Tatum Surgical Dental Implant System | 2022 | 1 |
| K113753 | Zimmer Dental Tapered Screw-Vent X | 2012 | 1 |
| K151928 | PUR Dental Implant System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2009 | Not classified | Z-0499-2010 | Process control | The devices may not meet specifications, which may result in fracturing during tightening of the component. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 26 ancestors have a recall of any class.
- Of its descendants, K072589 (Zimmer Dental, Inc., 2007) has gone furthest, with 98 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.
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®, Screw-Vent®, AdVent, and Zimmer®One-Piece 3.7 mm Dental 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.
Zimmer One-Piece 3.7 mm implants are limited to restorations (immediately loaded or loaded after a conventional healing period) in the premolar, cuspid, and incisor regions of partially edentulous jaws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061410: Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant System,AV;Zimmer One-Piece Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061410
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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