510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Screw-Vent Dental Implant System

K011028510(k) TraditionalCleared May 21, 200146-day reviewClass II21 CFR 872.3640Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sulzer Dental, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on May 21, 2001 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 184 later devices descend from it. It has been recalled 2 times.

Decided
May 21, 2001
Review
46 days
Class
Class II
Product code
DZE
Recalls
2
Predicates
0

184 later devices descend from it, 16 citing it directly.

Descendants, by year cleared 2006: 3 descendants cleared2007: 3 descendants cleared2010: 3 descendants cleared2014: 7 descendants cleared2009: 2 descendants cleared2013: 4 descendants cleared2012: 4 descendants cleared2015: 10 descendants cleared2011: 4 descendants cleared2008: 3 descendants cleared2020: 10 descendants cleared2021: 12 descendants cleared2018: 4 descendants cleared2017: 4 descendants cleared2016: 5 descendants cleared2024: 20 descendants cleared2019: 11 descendants cleared2025: 24 descendants cleared2022: 16 descendants cleared2026: 14 descendants cleared2023: 21 descendants cleared200020052010201520202025
  1. This deviceK011028 Screw-Vent Dental Implant SystemSulzer Dental, Inc. · 2001
  2. Descendant · cites it directly · 94 of its ownK101880 Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc. · 2010 · Recalled
  3. Descendant · cites it directly · 88 of its ownK112160 Tapered Screw-Vent X ImplantZimmer Dental, Inc. · 2011 · Recalled
  4. Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
  5. Descendant · 2 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
  6. Descendant · 3 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019

Showing 5 of 184 descendants. See all descendants

Descendants cleared per year

2006: 32007: 32008: 32009: 22010: 32011: 42012: 42013: 42014: 72015: 102016: 52017: 42018: 42019: 112020: 102021: 122022: 162023: 212024: 202025: 242026: 14
2006high 24 (2025) · low 2 (2009)2026

Most influential descendants

Showing 5 of 184 · See all
  • 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
  • K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 3 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011028Screw-Vent Dental Implant SystemSulzer Dental, Inc.2001—
+1K101880Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc.20101
+1K112160Tapered Screw-Vent X ImplantZimmer Dental, Inc.201119
+2K170588DESS Dental Smart SolutionsTerrats Medical SL2017—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL2018—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
200730
200830
200920
201030
201140
201240
201340
201470
2015100
201650
201740
201840
2019110
2020100
2021120
2022160
2023210
2024200
2025240
2026140
FIG. 1 — Lineage of K011028, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (184)

See all 184

16 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101880Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc.201094
K112160Tapered Screw-Vent X ImplantZimmer Dental, Inc.201188
K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927
K113779Conelog Implant SystemAltatec GmbH201214
K053373Atlantis Abutment for Zimmer InterfaceAtlantis Components, Inc.200613
K121406Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc.201311
K081101Spectra-System Abutments 2008Implant Direct, LLC200911
K062931Implus Implant SystemLeader Italia S.R.L.20074
K050956TBR Idea Conic/ConicSudimplant SA20062
K113753Zimmer Dental Tapered Screw-Vent XZimmer Dental, Inc.20121

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 10, 2017Class IIZ-3206-2017Under Investigation by firmZimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
Jul 17, 2014Class IIZ-2144-2014Process designZimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K101880 (Zimmer Dental, Inc., 2010) has gone furthest, with 94 descendants of its own.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
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

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

More from Sulzer Dental, Inc.

9 FDA decisions under this applicant name. See the company

  • K014050Hex-Lock Temporary AbutmentSulzer Dental, Inc. · 2002
  • K014175Sulzer Dental Ceramic System-HexlockSulzer Dental, Inc. · 2002
  • K014214Sulzer Dental Ceramic System-SplineSulzer Dental, Inc. · 2002
  • K0134943.75MM and 5.0MM Spline Twist ImplantSulzer Dental, Inc. · 2002
  • K013227Screw Vent Implant; Tapered Screw Vent ImplantSulzer Dental, Inc. · 20012 recalls

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K011028 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011028: Screw-Vent Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011028

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026