510(k) · Cleared
ClearedArgenIS Titanium Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Argen Corporation · NHA Abutment, Implant, Dental, Endosseous
Cleared on Sep 16, 2015 as substantially equivalent to K062566 (Nobel Biocare USA, LLC, 2006) and 6 other predicates after a 328-day review. Its family tree reaches back 9 generations to 1990. 2 later devices descend from it.
- Decided
- Sep 16, 2015
- Review
- 328 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K894595 (1990). 107 ancestors in all, the oldest K871863 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 2 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 1 generation backK081419 Straumann Dental Implant SystemInstitut Straumann AG · 2009
- This deviceK143051 ArgenIS Titanium AbutmentsThe Argen Corporation · 2015
- Descendant · cites it directly · 1 of its ownK160248 ArgenIS Titanium AbutmentsArgen Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK172430 ArgenIS Titanium AbutmentsArgen Corporation · 2018
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 backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 6 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 3 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 2 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 1 generation backK081419 Straumann Dental Implant SystemInstitut Straumann AG · 2009
- This deviceK143051 ArgenIS Titanium AbutmentsThe Argen Corporation · 2015
Most influential descendants
Showing 2 of 2 · See allView 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 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −6 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −3 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −2 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −1 | K081419 | Straumann Dental Implant System | Institut Straumann AG | 2009 | — |
| 0 (this device) | K143051 | ArgenIS Titanium Abutments | The Argen Corporation | 2015 | — |
| +1 | K160248 | ArgenIS Titanium Abutments | Argen Corporation | 2016 | — |
| +2 | K172430 | ArgenIS Titanium Abutments | Argen Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 11 | 0 |
| 1994 | 9 | 0 |
| 1995 | 7 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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? (7)
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 |
|---|---|---|---|
| * | K062566 | Nobelreplace Tapered Conical ConnectionSummary page 4…is claimed (Predicate Devices): Primary Predicate Trade Name: Nobel Biocare Replace Select 510(k) Number: K062566 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name:… | 2006 |
| * | K130949 | CP4 Osseotite Certain Dental ImplantsSummary page 4…Implant, Endosseous, Root-Form Predicate Device No. 2 Trade Name: Biomet 3i Certain 510(k) Number: K130949 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name:… | 2013 |
| * | K081419 | Straumann Dental Implant SystemSummary page 4…Implant, Endosseous, Root-Form Predicate Device No. 3 Trade Name: Straumann SynOcta 510(k) Number: K081419 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name:… | 2009 |
| * | K133339 | Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M…Summary page 5…ArgenIS Titanium Abutments Predicate Device No. 4 Trade Name: Zimmer Tapered Screw-Vent 510(k) Number: K133339 Regulation Number: 872.3640 Classification Code: DZE Device Classification Name:… | 2014 |
| * | K083192 | Inclusive Titanium Abutment BlanksSummary page 5…Endosseous, Root-Form Predicate Device No. 5 Trade Name: Inclusive Titanium Abutment Blanks 510(k) Number: K083192 Regulation Number: 872.3630 Classification Code: NHA Device Classification Name:… | 2009 |
| * | K130183 | Sfi Bar AbutmentsSummary page 5…plant Abutment Predicate Device No. 6 Trade Name: SFI Bar® Implant Abutments for 7 Platforms 510(k) Number: K130183 Regulation Number: 872.3630 Classification Code: NHA Device Classification Name:… | 2013 |
| * | K132814 | Sfi-Bar Implant AbutmentsSummary page 5…lant Abutment Predicate Device No. 7 Trade Name: SFI Bar® Implant Abutments for 9 Platforms 510(k) Number: K132814 Regulation Number: 872.3630 Classification Code: NHA Device Classification Name:… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160248 | ArgenIS Titanium Abutments | 2016 | 1 |
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 1.7 years on median.
- 19 of the 107 ancestors have a recall of any class.
- Of its descendants, K160248 (Argen Corporation, 2016) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K062566.
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?
ArgenIS patient specific abutments are intended to be single use available by prescription only to dental professionals (dental technicians and Dentists) in the construction of dental restorations supported by endosseous dental implants. The Argen Is Abutment is designed to specifically fit an individual patients needs in order to more naturally support the tissue, esthetics, and function of the final restoration. The ArgenIS titanium abutments are…
Read the full statement (138 words)
ArgenIS patient specific abutments are intended to be single use available by prescription only to dental professionals (dental technicians and Dentists) in the construction of dental restorations supported by endosseous dental implants. The Argen Is Abutment is designed to specifically fit an individual patients needs in order to more naturally support the tissue, esthetics, and function of the final restoration.
The ArgenIS titanium abutments are compatible with the following implant systems:
Implant Brand and Type Implant Diameter
Nobel Biocare Replace Select 3.5mm
Nobel Biocare Replace Select 4.3mm
Nobel Biocare Replace Select 5.0mm
Biomet 3i Certain 3.25mm
Biomet 3i Certain 4.0mm
Biomet 3i Certain 5.0mm
Straumann Tissue Level - RN 3.3mm
Straumann Tissue Level - RN 4.1mm
Straumann Tissue Level - RN 4.8mm
Zimmer Tapered Screw-Vent 3.7mm
Zimmer Tapered Screw-Vent 4.1mm
Zimmer Tapered Screw-Vent 4.7mm
Zimmer Tapered Screw-Vent 6.0mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143051: ArgenIS Titanium Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143051
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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