510(k) · Cleared
Recalled · Class II · 2014Tapered Screw-Vent T Implant, Tapered Screw-Vent P 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 Oct 1, 2010 as substantially equivalent to K011028 (Sulzer Dental, Inc., 2001) and 6 other predicates after an 87-day review. Its family tree reaches back 8 generations to 1990. 94 later devices descend from it. It has been recalled once.
- Decided
- Oct 1, 2010
- Review
- 87 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 8 generations to K894595 (1990). 34 ancestors in all. 94 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 4 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 3 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 2 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 1 generation backK062566 Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC · 2006 · Recalled
- This deviceK101880 Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc. · 2010
- 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
- Descendant · 3 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- Descendant · 3 generations on · 22 of its ownK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- 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
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 3 generations on38descendants
- K183518Preat AbutmentsPreat Corporation · 2019 · 3 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −4 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −3 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −2 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −1 | K062566 | Nobelreplace Tapered Conical Connection | Nobel Biocare USA, LLC | 2006 | 27 |
| 0 (this device) | K101880 | Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant | Zimmer Dental, Inc. | 2010 | — |
| +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 | — |
| +3 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| +3 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 13 | 0 |
| 2024 | 14 | 0 |
| 2025 | 22 | 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? (7)
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 |
|---|---|---|---|
| * | K011028 | Screw-Vent Dental Implant SystemSummary page 1…ndosseous Dental Implant 2. Predicate Device(s): a. Zimmer Dental Tapered Screw-Vent®)Implant System i. 510(k) Numbers: K011028 /K953101/IK013227/IK061410 I K072589 b. NobelReplace Tapered Conical Connection… | 2001 |
| * | K953101 | Paragon Implant SystemSummary page 1…Dental Implant 2. Predicate Device(s): a. Zimmer Dental Tapered Screw-Vent®)Implant System i. 510(k) Numbers: K011028 /K953101/IK013227/IK061410 I K072589 b. NobelReplace Tapered Conical Connection… | 1995 |
| * | K013227 | Screw Vent Implant; Tapered Screw Vent ImplantSummary page 1…mplant 2. Predicate Device(s): a. Zimmer Dental Tapered Screw-Vent®)Implant System i. 510(k) Numbers: K011028 /K953101/IK013227/IK061410 I K072589 b. NobelReplace Tapered Conical Connection i.… | 2001 |
| * | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Summary page 1…2. Predicate Device(s): a. Zimmer Dental Tapered Screw-Vent®)Implant System i. 510(k) Numbers: K011028 /K953101/IK013227/IK061410 I K072589 b. NobelReplace Tapered Conical Connection i. 510(k) N… | 2006 |
| * | K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11…Summary page 1…a. Zimmer Dental Tapered Screw-Vent®)Implant System i. 510(k) Numbers: K011028 /K953101/IK013227/IK061410 I K072589 b. NobelReplace Tapered Conical Connection i. 510(k) Number: K062566 c. Sp… | 2007 |
| * | K062566 | Nobelreplace Tapered Conical ConnectionSummary page 1…011028 /K953101/IK013227/IK061410 I K072589 b. NobelReplace Tapered Conical Connection i. 510(k) Number: K062566 c. Spline X Implant i. 510(k). Number: K962576 4. Device Description:… | 2006 |
| * | K962576 | Spline X Endosseous Dental Implant SystemSummary page 1…b. NobelReplace Tapered Conical Connection i. 510(k) Number: K062566 c. Spline X Implant i. 510(k). Number: K962576 4. Device Description: The Tapered Screw-Vent® T Implant is an endosseous dental implant. The… | 1997 |
What descends from it? (94)
See all 943 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 |
|---|---|---|---|---|
| Jun 25, 2014 | Class II | Z-2050-2014 | Under Investigation by firm | Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 11 of the 34 ancestors have a recall of any class.
- Of its descendants, K112160 (Zimmer Dental, Inc., 2011) has gone furthest, with 88 descendants of its own.
- 15 other devices also cite its predicate K011028.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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®T 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 toad.
The Tapered Screw-Vent® P Implants are designed for use in the maxilla or mandible for loading after a conventional healing period. Implants may be used to replace one or more missing teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101880 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101880: Tapered Screw-Vent T Implant, Tapered Screw-Vent P Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101880
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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