510(k) Report

510(k) · Cleared

Cleared

Zimmer Patient-Specific Abutment, Internal Hex, Titanium

K071439510(k) TraditionalCleared Sep 20, 2007120-day reviewClass II21 CFR 872.3640

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

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

Cleared on Sep 20, 2007 after a 120-day review. The FDA summary names its predicate without a number. 31 later devices descend from it.

Decided
Sep 20, 2007
Review
120 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

31 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2015: 4 descendants cleared2012: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2008: 1 descendant cleared2014: 4 descendants cleared2018: 1 descendant cleared2020: 3 descendants cleared2022: 1 descendant cleared2016: 1 descendant cleared2017: 3 descendants cleared2021: 4 descendants cleared2023: 2 descendants cleared2024: 4 descendants cleared20052010201520202025
  1. This deviceK071439 Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc. · 2007
  2. Descendant · cites it directly · 16 of its ownK120873 Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc. · 2012
  3. Descendant · 2 generations on · 14 of its ownK134045 Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for…Zimmer Dental, Inc. · 2014
  4. Descendant · 3 generations on · 12 of its ownK141544 Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc. · 2014
  5. Descendant · cites it directly · 8 of its ownK143505 Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc. · 2015
  6. Descendant · 2 generations on · 7 of its ownK181037 DIO CAD/CAM AbutmentDio Corporation · 2018

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12012: 12013: 12014: 42015: 42016: 12017: 32018: 12020: 32021: 42022: 12023: 22024: 4
2008high 4 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 31 · See all
  • K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc. · 2012 · cites it directly16descendants
  • K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc. · 2014 · 2 generations on14descendants
  • K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc. · 2014 · 3 generations on12descendants
  • K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc. · 2015 · cites it directly8descendants
  • K181037DIO CAD/CAM AbutmentDio Corporation · 2018 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K071439Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.2007—
+1K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.2012—
+2K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive…Zimmer Dental, Inc.2014—
+3K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.2014—
+1K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.2015—
+2K181037DIO CAD/CAM AbutmentDio Corporation2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201210
201310
201440
201540
201610
201730
201810
202030
202140
202210
202320
202440
FIG. 1 — Lineage of K071439, 2007–2024Source: 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), 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. #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? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Zimmer® Hex-Lock Abutment, 3.5mm (cat. No. HLA3/3)
Named without a submission number
—

What descends from it? (31)

See all 31

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

NumberDeviceApplicantDecidedDescendants
K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216
K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158
K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137
K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083
K142572Zimmer Zfx Abutment for Zimmer 3.1mmD Implant SystemZimmer Dental, Inc.20150
K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100

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?

  • Of its descendants, K120873 (Zimmer Dental, Inc., 2012) has gone furthest, with 16 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. 2007, this device’s year, is highlighted.

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—

What is it indicated for?

The Zimmer® Patient Specific Abutment, Internal Hex, Titanium is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration.

Indications for use as stated in the FDA summary.

More from Zimmer Dental, Inc.

40 FDA decisions under this applicant name. See the company

  • K160398MRI Compatibility for Existing Zimmer Dental Implant SystemsZimmer Dental, Inc. · 2017
  • K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc. · 2015
  • K143528Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant SystemZimmer Dental, Inc. · 2015
  • K142572Zimmer Zfx Abutment for Zimmer 3.1mmD Implant SystemZimmer Dental, Inc. · 2015
  • K142082Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour AbutementZimmer Dental, Inc. · 2014

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/K071439 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071439: Zimmer Patient-Specific Abutment, Internal Hex, Titanium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071439

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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