510(k) · Cleared
ClearedDuranext Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elegant Dental Corp. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 22, 2020 as substantially equivalent to K150203 (Medentika GmbH, 2015) and 3 other predicates after a 160-day review. Its family tree reaches back 15 generations to 1990.
- Decided
- Jul 22, 2020
- Review
- 160 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K894844 (1990). 177 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 15 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 11 generations between
- 3 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 2 generations backK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- 1 generation backK160784 CAM Titanium BlanksAltatec GmbH · 2016
- This deviceK200355 Duranext AbutmentsElegant Dental Corp. · 2020
Show all 15 generations
- Root · 15 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 14 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 13 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 12 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 11 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 10 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 9 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 8 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 7 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 6 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 5 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 4 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 3 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 2 generations backK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- 1 generation backK160784 CAM Titanium BlanksAltatec GmbH · 2016
- This deviceK200355 Duranext AbutmentsElegant Dental Corp. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −14 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −13 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −12 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −11 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −10 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −9 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −8 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −7 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −6 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −5 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −4 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −3 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −2 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| −1 | K160784 | CAM Titanium Blanks | Altatec GmbH | 2016 | — |
| 0 (this device) | K200355 | Duranext Abutments | Elegant Dental Corp. | 2020 | — |
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 |
| 1992 | 1 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 8 | 0 |
| 1996 | 13 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 8 | 0 |
| 2006 | 13 | 0 |
| 2007 | 13 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K150203 | Medentika CAD/CAM AbutmentsSummary page 4…tion Panel Dental Products Panel Reviewing Division DHT1B: Division of Dental Devices PREDICATE DEVICE INFORMATION Primary predicate device: K150203 Medentika CAD/CAM Abutments, Medentika GmbH Reference devices: K160784 CAM Titanium Blanks, Altatec GmbH… | 2015 |
| * | K160784 | CAM Titanium BlanksSummary page 4…T1B: Division of Dental Devices PREDICATE DEVICE INFORMATION Primary predicate device: K150203 Medentika CAD/CAM Abutments, Medentika GmbH Reference devices: K160784 CAM Titanium Blanks, Altatec GmbH K171799 Elos Accurate Customized Abutment, Elos Medtech Pinol A/S… | 2016 |
| * | K171799 | Elos Accurate Customized Abutment, Elos Prosthetic ScrewSummary page 4…predicate device: K150203 Medentika CAD/CAM Abutments, Medentika GmbH Reference devices: K160784 CAM Titanium Blanks, Altatec GmbH K171799 Elos Accurate Customized Abutment, Elos Medtech Pinol A/S K134045 Zimmer Zfx Ti Abutment for NobelAct… | 2018 |
| * | K134045 | Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Summary page 4…K160784 CAM Titanium Blanks, Altatec GmbH K171799 Elos Accurate Customized Abutment, Elos Medtech Pinol A/S K134045 Zimmer Zfx Ti Abutment for NobelActive, NobelReplace CC, Zimmer Dental Inc. 510(k) Su… | 2014 |
| † | K183518 | Preat Abutments | 2019 |
| † | K071370 | Nobelactive Internal Connection Implant | 2007 |
| † | K142260 | NobelActive | 2015 |
| † | K102436 | Nobel Active 3.0 | 2010 |
| † | K062566 | Nobelreplace Tapered Conical Connection | 2006 |
| † | K173418 | NobelParallel Conical Connection | 2019 |
| † | K050258 | Groovy Implants | 2005 |
| † | K011028 | Screw-Vent Dental Implant System | 2001 |
| † | K112160 | Tapered Screw-Vent X Implant | 2011 |
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 30 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 19 of the 177 ancestors have a recall of any class.
- 13 other devices also cite its predicate K150203.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Duranext Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Implant System Compatibility | Implant Body Diameter, mm | Implant Platform NobelActive® (conical connection) | 3.0 | 3.0 (3.0 mm) NobelActive® (conical connection) | 3.5 | NP (3.5 mm) NobelActive® (conical connection) | 4.3, 5.0 | RP (3.9 mm) NobelActive® (conical…
Read the full statement (216 words)
Duranext Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Implant System Compatibility | Implant Body Diameter, mm | Implant Platform
NobelActive® (conical connection) | 3.0 | 3.0 (3.0 mm)
NobelActive® (conical connection) | 3.5 | NP (3.5 mm)
NobelActive® (conical connection) | 4.3, 5.0 | RP (3.9 mm)
NobelActive® (conical connection) | 5.5 | WP (5.1 mm)
NobelReplace Conical Connection | 3.5 | NP (3.5 mm)
NobelReplace Conical Connection | 4.3, 5.0 | RP (3.9 mm)
NobelParallel Conical Connection | 3.75 | NP (3.5 mm)
NobelParallel Conical Connection | 4.3, 5.0 | RP (3.9 mm)
NobelParallel Conical Connection | 5.5 | WP (5.1 mm)
NobelReplace® (Internal tri-channel) | 3.5 | NP (3.5 mm)
NobelReplace® (Internal tri-channel) | 4.3 | RP (4.3 mm)
NobelReplace® (Internal tri-channel) | 5.0 | WP (5.0 mm)
NobelReplace® (Internal tri-channel) | 6.0 | 6.0 (6.0 mm)
Zimmer Screw Vent®/ Tapered Screw-Vent® | 3.7, 4.1 | 3.5 mm
Zimmer Screw Vent®/ Tapered Screw-Vent® | 4.7 | 4.5 mm
Zimmer Screw Vent®/ Tapered Screw-Vent® | 6.0 | 5.7 mm
All digitally designed custom abutments for use with Duranext Abutments are to be sent to an Elegant Direct Corp. validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200355: Duranext Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200355
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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