510(k) · Cleared
ClearedZimmer ZFX Titanium Abutment for Straumann Bone Level 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 Jul 29, 2014 as substantially equivalent to K120873 (Zimmer Dental, Inc., 2012) and 3 other predicates after a 90-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Jul 29, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K894595 (1990). 85 ancestors in all, the oldest K871863 (1987). 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 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 deviceK141120 Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc. · 2014
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 deviceK141120 Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant SystemZimmer Dental, Inc. · 2014
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) | K141120 | Zimmer ZFX Titanium Abutment for Straumann Bone Level Implant System | Zimmer Dental, Inc. | 2014 | — |
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 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 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 |
|---|---|---|---|
| * | K120873 | Zimmer ZFX Abutment for Nobel Replace Implant SystemSummary page 1…Zimmer Zfx Abutment for NobelReplace Implant System 5 10(k) Number: K 120873 Regulation Number: 872.3630 Classification Code: NHA… | 2012 |
| * | K072151 | P.004 RC Cares Titanium and Ceramic AbutmentsSummary page 1…Predicate Device No. 2 Trade Name: Straumann Cares Abutment, Titanium 5 10(k) Number: K072 151 and K08 1005 Regulation Number: 872.3630 Classification Code: NHA… | 2007 |
| * | K081005 | P.004 NC Cares Titanium and Ceramic AbutmentsSummary page 1…cate Device No. 2 Trade Name: Straumann Cares Abutment, Titanium 5 10(k) Number: K072 151 and K08 1005 Regulation Number: 872.3630 Classification Code: NHA… | 2008 |
| * | K071357 | P.004 NC Anatomic AbutmentsSummary page 1…Predicate Device No. 3 Trade Name: Straumann Bone Level Anatomic Abutment 5 10(k) Number: K07 1357 Regulation Number: 872.3630 Classification Code> NHA… | 2007 |
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 24 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 85 ancestors have a recall of any class.
- 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 Straumann Bone Level Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Straumann Bane Level implants with a Narrow CrassFht Connection (NC) 03.3mm or Regular Crossflt Connection (RC) 04.1 mm or 04.8mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141120: Zimmer ZFX Titanium Abutment for Straumann Bone Level 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/K141120
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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