510(k) · Cleared
ClearedZimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive 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 Apr 25, 2014 as substantially equivalent to K120873 (Zimmer Dental, Inc., 2012) and 2 other predicates after a 115-day review. Its family tree reaches back 10 generations to 1990. 14 later devices descend from it.
- Decided
- Apr 25, 2014
- Review
- 115 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K894595 (1990). 77 ancestors in all, the oldest K871863 (1987). 14 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 2 generations backK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- 1 generation backK120873 Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc. · 2012
- This deviceK134045 Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for…Zimmer Dental, Inc. · 2014
- Descendant · cites it directly · 12 of its ownK141544 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 · 2 generations on · 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
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 backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 2 generations backK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- 1 generation backK120873 Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc. · 2012
- This deviceK134045 Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for…Zimmer Dental, Inc. · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc. · 2014 · cites it directly12descendants
- 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 · 2 generations on2descendants
- K222913s-Clean Link AbutmentDentis Co., Ltd. · 2023 · 3 generations on1descendant
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 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| −2 | K091756 | Nobelprocera TI Abutment | Nobel Biocare AB | 2009 | — |
| −1 | K120873 | Zimmer ZFX Abutment for Nobel Replace Implant System | Zimmer Dental, Inc. | 2012 | — |
| 0 (this device) | K134045 | Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive… | Zimmer Dental, Inc. | 2014 | — |
| +1 | 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 | — |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 9 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 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 30.7 · 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? (3)
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 |
|---|---|---|---|
| * | K120873 | Zimmer ZFX Abutment for Nobel Replace Implant SystemSummary page 1…ade Name: Zimmer Zfx Abutment for NobelReplace Implant System 5 10(k) Number: K(120873 Regulation Number: 872.3630 Classification Code: NHA Device Classification Name:… | 2012 |
| * | K091756 | Nobelprocera TI AbutmentSummary page 1…ndosseous Dental Implant Abutment Predicate Device No. 2 Trade Name: NobelProcera Ti Abutment 5 10(k) Number: K09 1756 Regulation Number: 872.3630 Classification Code: NHA Device Classification Name:… | 2009 |
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 1…Implant Abutment Predicate Device No. 3 Trade Name : Nobel Active Internal Connection Implant 5 10(k) Number: K071370 Regulation Number : 872.3640 Classification Code : DZE Device Classification Name :… | 2007 |
What descends from it? (14)
See all 143 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 1.9 years on median.
- 11 of the 77 ancestors have a recall of any class.
- Of its descendants, K141544 (Zimmer Dental, Inc., 2014) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K120873.
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 NobelActive Implant System is designed
for use as a terminal or intermediate abutment for cement retained prostheses.
The abutment can be used with NobelActive and NobeiReplace Conical
Connection implants with a Narrow Platform (NP) 0 3.5mm or Regular Platform
(RP) 0 3.9mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K134045: Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive 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/K134045
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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