# K192457: Elos Accurate Customized Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Elos Medtech Pinol A/S
- Decided: Jan 2, 2020 after 115 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: 16 generations back to K894844 (1990). 173 ancestors in all.
6 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 4.

## Most influential descendants
- K222044: Elos Accurate Customized Abutment (2022), 4 descendants of its own
- 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. Elos Accurate Customized Abutment – Model Type | Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] AB-NBR43 | Nobel Replace RP | 4.3 | 4.3 AB-NBR50 | Nobel Replace WP | 5 | 5 AB-NBR60 | Nobel Replace 6.0 | 6 | 6 AB-NBA35 | Nobel CC NP | 3.5 | 3.5 & 3.75 All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.

Source page: https://510kreport.com/device/K192457
Methodology: https://510kreport.com/methodology