510(k) · Cleared
ClearedZimmer Dental Trabecular Metal Implant System
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 Nov 19, 2013 as substantially equivalent to K112160 (Zimmer Dental, Inc., 2011) and 3 other predicates after a 123-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Nov 19, 2013
- Review
- 123 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K894595 (1990). 37 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK062566 Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC · 2006 · Recalled
- 2 generations backK101880 Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc. · 2010 · Recalled
- 1 generation backK112160 Tapered Screw-Vent X ImplantZimmer Dental, Inc. · 2011 · Recalled
- This deviceK132258 Zimmer Dental Trabecular Metal Implant SystemZimmer Dental, Inc. · 2013
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 7 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 6 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 5 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 4 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 3 generations backK062566 Nobelreplace Tapered Conical ConnectionNobel Biocare USA, LLC · 2006 · Recalled
- 2 generations backK101880 Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc. · 2010 · Recalled
- 1 generation backK112160 Tapered Screw-Vent X ImplantZimmer Dental, Inc. · 2011 · Recalled
- This deviceK132258 Zimmer Dental Trabecular Metal Implant SystemZimmer Dental, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −7 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −6 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −5 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −4 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −3 | K062566 | Nobelreplace Tapered Conical Connection | Nobel Biocare USA, LLC | 2006 | 27 |
| −2 | 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 |
| 0 (this device) | K132258 | Zimmer Dental Trabecular Metal Implant System | Zimmer Dental, Inc. | 2013 | — |
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 |
| 2012 | 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? (4)
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 |
|---|---|---|---|
| * | K112160 | Tapered Screw-Vent X ImplantSummary page 1…edicate Device(s): Predicate Device No. I Trade Name: Trabecular ScrewVent X Implant 510(k): K112160,K113753 Regulation Number: 872.3640 Classification Code: DZE Device Classi… | 2011 |
| * | K113753 | Zimmer Dental Tapered Screw-Vent XSummary page 1…Device(s): Predicate Device No. I Trade Name: Trabecular ScrewVent X Implant 510(k): K112160,K113753 Regulation Number: 872.3640 Classification Code: DZE Device Classification… | 2012 |
| * | K013227 | Screw Vent Implant; Tapered Screw Vent ImplantSummary page 1…t, Endosseous, Root-Form Predicate Device No. 2 Trade Name: Screw Vent Dental Implant 510(k): K0 13227, K06141 0 Regulation Number: 872.3640 Classification Code: DZE Device Clas… | 2001 |
| * | K061410 | Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Summary page 1…ous, Root-Form Predicate Device No. 2 Trade Name: Screw Vent Dental Implant 510(k): K0 13227, K06141 0 Regulation Number: 872.3640 Classification Code: DZE Device Clasjification… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 13 of the 37 ancestors have a recall of any class.
- 2 other devices also cite its predicate K112160.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Zimmer Trabecular Metal Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed 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 3.7mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the pre-molar region and…
Read the full statement (127 words)
The Zimmer Trabecular Metal Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed 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 3.7mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
The 4.1mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the molar region.
The 4.1mmD x 8mmL Zimmer Trabecular Metal Implant should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132258: Zimmer Dental Trabecular Metal Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132258
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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