510(k) · Cleared
Recalled · Class II · 20143.25 Spline Twist Implant, HA Coated
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 15, 2009 as substantially equivalent to K944327 (Calcitek, Inc., 1995) and 1 other predicate after a 70-day review. Its family tree reaches back 2 generations to 1995. It has been recalled once.
- Decided
- Dec 15, 2009
- Review
- 70 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944327 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944327 | Integral VI Biointegrated Dental Implant System | Calcitek, Inc. | 1995 | — |
| −1 | K012055 | 3.25MM Spline Twist Implant | Sulzer Dental, Inc. | 2001 | — |
| 0 (this device) | K093164 | 3.25 Spline Twist Implant, HA Coated | Zimmer Dental, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 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? (2)
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 |
|---|---|---|---|
| * | K944327 | Integral VI Biointegrated Dental Implant SystemSummary page 1…Integral VI Biointegrated Dental Implant System 510(k) Number: K944327 Classification: DZE Classification Name: Endosseous Dental Imp… | 1995 |
| * | K012055 | 3.25MM Spline Twist ImplantSummary page 1…Predicate Device #2 Trade Name: Small Diameter Spline Twist Implant 510(k) Number: K012055 Classification: DZE 3.25mm Spline®g Twist1" 4 Implant, HA Coated 51… | 2001 |
| † | K960021 | Calcitek HA-Coated Endosseous Dental Implant Systems | 1996 |
| † | K953101 | Paragon Implant System | 1995 |
| † | K011028 | Screw-Vent Dental Implant System | 2001 |
| † | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | 2001 |
| † | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant… | 2006 |
| † | K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2014 | Class II | Z-0153-2015 | Labeling Change Control | Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K944327.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The threaded implants should only be immediately loaded when good primary stability is achieved and the functional load is appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093164: 3.25 Spline Twist Implant, HA Coated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093164
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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