# K242025: Elos Accurate® Hybrid Base™

- Pathway: 510(k) (Traditional)
- Applicant: Elos Medtech Pinol A/S
- Decided: Dec 10, 2024 after 152 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: 20 generations back to K960026 (1996). 321 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 324 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230317: Elos Accurate Hybrid Base, Elos Medtech Pinol A/S (2023) Summary page 5.

## Most influential descendants
- K261327: Elos Accurate Hybrid Base (2026), 0 descendants of its own
- K251497: Elos Accurate Hybrid Base (2025), 0 descendants of its own

## Indications for use
The Elos Accurate® Hybrid Base TM is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base TM is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base TM is compatible with the implant systems listed in table 1: The zirconia superstructures for use with the Elos Accurate® Hybrid Base TM 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, ceramic material, milling machine and associated tooling and accessories.

Source page: https://510kreport.com/device/K242025
Methodology: https://510kreport.com/methodology