# K171799: Elos Accurate Customized Abutment, Elos Prosthetic Screw

- Pathway: 510(k) (Traditional)
- Applicant: Elos Medtech Pinol A/S
- Decided: Jan 15, 2018 after 213 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: 14 generations back to K894844 (1990). 171 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 187 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.

## Most influential descendants
- K190299: Elos Accurate® Customized Abutment (2019), 13 descendants of its own
- K192457: Elos Accurate Customized Abutment (2020), 6 descendants of its own
- K191890: Elos Accurate Customized Abutment (2020), 5 descendants of its own
- K222044: Elos Accurate Customized Abutment (2022), 4 descendants of its own
- K193425: Pre-Milled Blank (2020), 4 descendants of its own

## Indications for use
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the following implant systems: Ref. No. AB-BRA411213-US — Platform compatibility: Nobel Biocare® / Brånemark® RP — Implant diameter: 3.75 mm & 4 mm Ref. No. AB-BRA351213-US — Platform compatibility: Nobel Biocare® / Brånemark® NP — Implant diameter: 3.3 mm Ref. No. AB-BRA511213-US — Platform compatibility: Nobel Biocare® / Brånemark® WP — Implant diameter: 5 mm All digitally designed Elos Accurate® Customized Abutments are intended to be manufactured at an Elos Medtech approved milling facility.

Source page: https://510kreport.com/device/K171799
Methodology: https://510kreport.com/methodology