510(k) · Cleared
ClearedZimmer ZFX Titanium Abutment for Biomet 3I Certain Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Dental, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 22, 2014 as substantially equivalent to K134045 (Zimmer Dental, Inc., 2014) and 3 other predicates after a 134-day review. Its family tree reaches back 11 generations to 1990. 12 later devices descend from it.
- Decided
- Oct 22, 2014
- Review
- 134 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K894595 (1990). 122 ancestors in all, the oldest K781060 (1978). 12 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- 2 generations backK120873 Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc. · 2012
- 1 generation backK134045 Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for…Zimmer Dental, Inc. · 2014
- This deviceK141544 Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc. · 2014
- Descendant · cites it directly · 8 of its ownK143505 Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK181037 DIO CAD/CAM AbutmentDio Corporation · 2018
- Descendant · cites it directly · 2 of its ownK160850 Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017
- Descendant · 3 generations on · 1 of its ownK222913 s-Clean Link AbutmentDentis Co., Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK210362 s-Clean Pre-Milled AbutmentDentis Co., Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 8 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 7 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 6 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 5 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 4 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 3 generations backK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- 2 generations backK120873 Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc. · 2012
- 1 generation backK134045 Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for…Zimmer Dental, Inc. · 2014
- This deviceK141544 Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc. · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc. · 2015 · cites it directly8descendants
- K181037DIO CAD/CAM AbutmentDio Corporation · 2018 · 2 generations on7descendants
- K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017 · cites it directly2descendants
- K222913s-Clean Link AbutmentDentis Co., Ltd. · 2023 · 3 generations on1descendant
- K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −8 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −7 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −6 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −5 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −4 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| −3 | K091756 | Nobelprocera TI Abutment | Nobel Biocare AB | 2009 | — |
| −2 | K120873 | Zimmer ZFX Abutment for Nobel Replace Implant System | Zimmer Dental, Inc. | 2012 | — |
| −1 | K134045 | Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive… | Zimmer Dental, Inc. | 2014 | — |
| 0 (this device) | K141544 | Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant System | Zimmer Dental, Inc. | 2014 | — |
| +1 | K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium | Zimmer Dental, Inc. | 2015 | — |
| +2 | K181037 | DIO CAD/CAM Abutment | Dio Corporation | 2018 | — |
| +1 | K160850 | Nucleoss Tpure Implant System | Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti | 2017 | — |
| +3 | K222913 | s-Clean Link Abutment | Dentis Co., Ltd. | 2023 | — |
| +3 | K210362 | s-Clean Pre-Milled Abutment | Dentis Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 5 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 10 | 0 |
| 1994 | 9 | 0 |
| 1995 | 11 | 0 |
| 1996 | 11 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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 |
|---|---|---|---|
| * | K134045 | Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Summary page 4…Zimmer Zfx Abutment for NobelActive Implant System 510(k) Number: K134045 Regulation Number: 872.3630 Classification Code: NHA… | 2014 |
| * | K032263 | 3I Patient-Specific Dental Abutment and Overdenture BarSummary page 4…Predicate Device No. 2 Trade Name: Biomet 3i BellaTek Definitive Abutment 510(k) Number: K032263/K052648 Regulation Number: 872.3630 Classification Code: NHA… | 2004 |
| * | K052648 | Modification to 3I Patient-Specific Dental Abutments and Overdenture BarsSummary page 4…ate Device No. 2 Trade Name: Biomet 3i BellaTek Definitive Abutment 510(k) Number: K032263/K052648 Regulation Number: 872.3630 Classification Code: NHA… | 2005 |
| * | K063341 | 3I Osseotite Certain Dental ImplantsSummary page 4…evice No. 3 ` Trade Name: Biomet 3i Certain GingiHue Abutment 510(k) Number: K063341 Regulation Number: 872.3640 Classification Code: DZE… | 2007 |
What descends from it? (12)
See all 122 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)
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 24 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 17 of the 122 ancestors have a recall of any class.
- Of its descendants, K143505 (Zimmer Dental, Inc., 2015) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K134045.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Biomet 3i internal connection implants with a 3.4mm, 4.1mm, 5.0mm, or 6.0mm Platform.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141544 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141544: Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141544
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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