# K200355: Duranext Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Elegant Dental Corp.
- Decided: Jul 22, 2020 after 160 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K894844 (1990). 177 ancestors in all.
No later device cites it as a predicate yet.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150203: Medentika CAD/CAM Abutments, Medentika GmbH (2015) Summary page 4.
- K160784: CAM Titanium Blanks, Altatec GmbH (2016) Summary page 4.
- K171799: Elos Accurate Customized Abutment, Elos Prosthetic Screw, Elos Medtech Pinol A/S (2018) Summary page 4.
- K134045: Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant System, Zimmer Dental, Inc. (2014) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K200355
Methodology: https://510kreport.com/methodology