510(k) · Cleared
ClearedZimmer Patient-Specific Abutment, Internal Hex, Titanium
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 Jun 25, 2015 as substantially equivalent to K071439 (Zimmer Dental, Inc., 2007) and 2 other predicates after a 197-day review. Its family tree reaches back 12 generations to 1990. 8 later devices descend from it.
- Decided
- Jun 25, 2015
- Review
- 197 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K894595 (1990). 123 ancestors in all, the oldest K781060 (1978). 8 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK120873 Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc. · 2012
- 2 generations backK134045 Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for…Zimmer Dental, Inc. · 2014
- 1 generation backK141544 Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc. · 2014
- This deviceK143505 Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc. · 2015
- Descendant · cites it directly · 7 of its ownK181037 DIO CAD/CAM AbutmentDio Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK222913 s-Clean Link AbutmentDentis Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK210362 s-Clean Pre-Milled AbutmentDentis Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK242703 LW Pre-milled AbutmentOssvis Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK232170 Ti Link AbutmentIzenimplant Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 8 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 7 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 6 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 5 generations backK062749 SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic…Nobel Biocare AB · 2006
- 4 generations backK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- 3 generations backK120873 Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc. · 2012
- 2 generations backK134045 Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for…Zimmer Dental, Inc. · 2014
- 1 generation backK141544 Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc. · 2014
- This deviceK143505 Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K181037DIO CAD/CAM AbutmentDio Corporation · 2018 · cites it directly7descendants
- K222913s-Clean Link AbutmentDentis Co., Ltd. · 2023 · 2 generations on1descendant
- K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd. · 2021 · 2 generations on1descendant
- K242703LW Pre-milled AbutmentOssvis Co., Ltd. · 2024 · 3 generations on0descendants
- K232170Ti Link AbutmentIzenimplant Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −8 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −7 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −6 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −5 | K062749 | SBF 15 Esthetic Abutment 1MM NP, Model 33699, SFB 15 Esthetic Abutment 1MM RP… | Nobel Biocare AB | 2006 | — |
| −4 | K091756 | Nobelprocera TI Abutment | Nobel Biocare AB | 2009 | — |
| −3 | K120873 | Zimmer ZFX Abutment for Nobel Replace Implant System | Zimmer Dental, Inc. | 2012 | — |
| −2 | 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 | — |
| 0 (this device) | K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium | Zimmer Dental, Inc. | 2015 | — |
| +1 | K181037 | DIO CAD/CAM Abutment | Dio Corporation | 2018 | — |
| +2 | K222913 | s-Clean Link Abutment | Dentis Co., Ltd. | 2023 | — |
| +2 | K210362 | s-Clean Pre-Milled Abutment | Dentis Co., Ltd. | 2021 | — |
| +3 | K242703 | LW Pre-milled Abutment | Ossvis Co., Ltd. | 2024 | — |
| +2 | K232170 | Ti Link Abutment | Izenimplant Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K071439 | Zimmer Patient-Specific Abutment, Internal Hex, TitaniumSummary page 4…Zimmer® Patient Specific Abutment, Internal Hex, Titanium 510(k) Number: K071439 Regulation Number: 872.3630 Classification Code: NHA… | 2007 |
| * | K134045 | Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Summary page 4…Zimmer Zfx Abutment for Nobel Active Implant System 510(k) Number: K134045 Regulation Number: 872.3630 Classification Code: NHA… | 2014 |
| * | K141544 | Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemSummary page 4…mmer Zfx Titanium Abutment for Biomet 3i Certain Implant System 510(k) Number: K141544 Regulation Number: 872.3630 Zimmer® Patient Specific Abutment,… | 2014 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181037 | DIO CAD/CAM Abutment | 2018 | 7 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 17 of the 123 ancestors have a recall of any class.
- Of its descendants, K181037 (Dio Corporation, 2018) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K071439.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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® Patient Specific Abutment 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.
https://510kreport.com/device/K143505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143505: Zimmer Patient-Specific Abutment, Internal Hex, Titanium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143505
Report an extraction error
Are you the manufacturer?
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