# K190299: Elos Accurate® Customized Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Elos Medtech Pinol A/S
- Decided: Jun 26, 2019 after 135 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). 172 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 186 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171799: Elos Accurate Customized Abutment, Elos Prosthetic Screw, Elos Medtech Pinol A/S (2018) Summary page 4.

## Most influential descendants
- 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
- K223634: Customized Abutment (2023), 3 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 Platform diameter Implant Body diameter Platform compatibility Abutment – Model Type [mm] [mm] AB-NBR35 Nobel Replace NP 3.5 3.5 AB-NBA30 Nobel CC 3.0 3 3 AB-NBA43 Nobel CC RP 3.9 4.3 & 5 AB-NBA60 Nobel CC WP 5.1 5.5 AB-SBO33 Straumann Bone Level NC 3.3 3.3 AB-SBO41 Straumann Bone Level RC 4.1 & 4.8 4.1 & 4.8 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/K190299
Methodology: https://510kreport.com/methodology