510(k) · Cleared

Cleared

Zimmer ZFX Abutment for Nobel Replace Implant System

K120873510(k) TraditionalCleared Nov 8, 2012231-day reviewClass II21 CFR 872.3630

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

Zimmer Dental, Inc. · NHA Abutment, Implant, Dental, Endosseous

Cleared on Nov 8, 2012 as substantially equivalent to K071439 (Zimmer Dental, Inc., 2007) and 2 other predicates after a 231-day review. Its family tree reaches back 9 generations to 1990. 16 later devices descend from it.

Decided: Nov 8, 2012
Review: 231 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 3

Its longest line of descent runs back 9 generations to K894595 (1990). 75 ancestors in all, the oldest K871863 (1987). 16 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
5 generations between
3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
2 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
1 generation backK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
This deviceK120873 Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc. · 2012
Descendant · cites it directly · 14 of its ownK134045 Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for…Zimmer Dental, Inc. · 2014
Descendant · 2 generations on · 12 of its ownK141544 Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc. · 2014
Descendant · 2 generations on · 8 of its ownK143505 Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc. · 2015
Descendant · 3 generations on · 7 of its ownK181037 DIO CAD/CAM AbutmentDio Corporation · 2018
Descendant · 3 generations on · 2 of its ownK160850 Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017

Show all 9 generations

Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
7 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
6 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
5 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
4 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
3 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
2 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
1 generation backK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
This deviceK120873 Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc. · 2012

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2014high 3 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 16 · See all

K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc. · 2014 · cites it directly14descendants
K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc. · 2014 · 2 generations on12descendants
K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc. · 2015 · 2 generations on8descendants
K181037DIO CAD/CAM AbutmentDio Corporation · 2018 · 3 generations on7descendants
K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K894595	Bonefit R Screw Implants	Institut Straumann AG	1990	—
−8	K984104	Iti Dental Implant System	Straumann USA	1999	1
−7	K993595	Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon…	Nobel Biocare Uas, Inc.	2000	—
−6	K023113	Replace Tiunite Endosseous Implant	Nobel Biocare Uas, Inc.	2002	27
−5	K041661	Nobel Biocare Endosseous Implants	Nobel Biocare Uas, Inc.	2004	—
−4	K050258	Groovy Implants	Nobel Biocare AB	2005	28
−3	K061003	SFB & CFB Implants	Nobel Biocare AB	2006	—
−2	K062749	SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP…	Nobel Biocare AB	2006	—
−1	K091756	Nobelprocera TI Abutment	Nobel Biocare AB	2009	—
0 (this device)	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	—
+2	K141544	Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant System	Zimmer Dental, Inc.	2014	—
+2	K143505	Zimmer Patient-Specific Abutment, Internal Hex, Titanium	Zimmer Dental, Inc.	2015	—
+3	K181037	DIO CAD/CAM Abutment	Dio Corporation	2018	—
+3	K160850	Nucleoss Tpure Implant System	Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti	2017	—

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	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	3	0
2015	1	0
2017	1	0
2018	1	0
2020	2	0
2021	3	0
2023	2	0
2024	3	0

FIG. 1 — Lineage of K120873, 1990–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K071439	Zimmer Patient-Specific Abutment, Internal Hex, Titanium Summary page 1 …o. 1 Trade Name: Zimmer Patient-Specific Abutment, Internal Hex, Titanium 510(k) Number: K071439 Regulation Number: 872.3630 Classification Code: NHA Device Classification Name: Endlosse…	Zimmer Dental, Inc.	2007	—
*	K091756	Nobelprocera TI Abutment Summary page 1 …Endlosseous Dental Implant Abutment Predicate Device No. 2 Trade Name: Nobelrocera Ti Abutment 510(k) Number: K091756 Regulation Number: 872.3630 Classification Code: NHA Device Classification Name:…	Nobel Biocare AB	2009	—
*	K023113	Replace Tiunite Endosseous Implant Summary page 1 …ntal Implant Abutment Predicate Device No. 3 Trade Name: Replace TiUnite Endlosseous Implant 510(k) Number: K(023113 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name:…	Nobel Biocare Uas, Inc.	2002	27

Also cleared against K071439: 5 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K134045	Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…	Zimmer Dental, Inc.	2014	14
K141120	Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant System	Zimmer Dental, Inc.	2014	0

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 22 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
10 of the 75 ancestors have a recall of any class.
Of its descendants, K134045 (Zimmer Dental, Inc., 2014) has gone furthest, with 14 descendants of its own.
5 other devices also cite its predicate K071439.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · NHA

40in 2025

2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007high 211 (2021) · low 90 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NHA

1in 2025

2007high 36 (2016) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHA

838in 2025

2007high 858 (2015) · low 1 (2007)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 ZNx Abutment for Nobel Replace Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelReplace, Replace Select and NobelSpeedy Replace implants with a Narrow Platform (NP) 0 3.5 mm, Regular Platform (RP) 0 4.3 mm, Wide Platform (WP) 0 5.0 mm or 6.0 Platform (6.0) 0 6.0 mm.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120873 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120873: Zimmer ZFX Abutment for Nobel Replace 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/K120873

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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