# K222044: Elos Accurate Customized Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Elos Medtech Pinol A/S
- Decided: Nov 30, 2022 after 142 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: 17 generations back to K894844 (1990). 175 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190299: Elos Accurate® Customized Abutment, Elos Medtech Pinol A/S (2019) Summary page 5.
- K171799: Elos Accurate Customized Abutment, Elos Prosthetic Screw, Elos Medtech Pinol A/S (2018) Summary page 5.
- K192457: Elos Accurate Customized Abutment, Elos Medtech Pinol A/S (2020) Summary page 5.
- K191890: Elos Accurate Customized Abutment, Elos Medtech Pinol A/S (2020) Summary page 5.

## Most influential descendants
- K231307: Elos Accurate Customized Abutment (2023), 1 descendant of its own
- K223677: Titanium Abutment Blank Nobel Biocare N1 TCC (2023), 1 descendant of its own
- K250178: Adin Customized Abutments (2025), 0 descendants of its own
- 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. Implant Platform compatibility — Platform diameter [mm] — Implant Body diameter [mm] Nobel Replace NP — 3.5 — 3.5 Nobel Replace RP — 4.3 — 4.3 Nobel Replace WP — 5 — 5 Nobel Replace 6.0 — 6 — 6 Nobel CC 3.0 — 3 — 3 Nobel CC NP — 3.5 — 3.5 & 3.75 Nobel CC RP — 3.9 — 4.3 & 5 Nobel CC WP — 5.1 — 5.5 Straumann Bone Level NC — 3.3 — 3.3 Straumann Bone Level RC — 4.1 & 4.8 — 4.1 & 4.8 Astra Tech 3.5/4.0 — 3.5 & 4 — 3.5 & 4 Astra Tech 4.5/5.0 — 4.5 & 5 — 4.5 & 5 Astra Tech EV 3.6 — 3.6 — 3.6 Astra Tech EV 4.2 — 4.2 — 3.6 & 4.2 Astra Tech EV 4.8 — 4.8 — 4.2 & 4.8 Astra Tech EV 5.4 — 5.4 — 5.4 Brånemark NP — 3.5 — 3.3 Brånemark RP — 4.1 — 3.75, 4 & 5 Brånemark WP — 5.1 — 5 & 6 All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended 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/K222044
Methodology: https://510kreport.com/methodology