# K231307: Elos Accurate Customized Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Elos Medtech Pinol A/S
- Decided: Dec 21, 2023 after 230 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: 18 generations back to K894844 (1990). 176 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 178 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222044: Elos Accurate Customized Abutment, Elos Medtech Pinol A/S (2022) Summary page 5.

## Most influential descendants
- K243521: Conical Ti Base abutments (2025), 0 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 implant systems listed in Table 1: Table 1. Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 Biomet 3i Certain 4.1 | Ø4.1 | Ø4 Biomet 3i Certain 5.0 | Ø5 | Ø5 Biomet 3i Certain 6.0 | Ø6 | Ø6 Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 Straumann Standard WN | Ø6.5 | Ø4.8 Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø5/Ø6/Ø7 Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 Hiossen ET Regular | Ø4/Ø4.5/Ø5/Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/Ø5.5/Ø6/Ø7 All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

Source page: https://510kreport.com/device/K231307
Methodology: https://510kreport.com/methodology