# K230317: Elos Accurate Hybrid Base

- Pathway: 510(k) (Traditional)
- Applicant: Elos Medtech Pinol A/S
- Decided: Sep 1, 2023 after 207 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: 19 generations back to K960026 (1996). 320 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 325 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201860: Elos Accurate Hybrid Base, Elos Medtech Pinol A/S (2021) Summary page 4.

## Most influential descendants
- K242025: Elos Accurate® Hybrid Base™ (2024), 2 descendants of its own
- K261327: Elos Accurate Hybrid Base (2026), 0 descendants of its own
- K251497: Elos Accurate Hybrid Base (2025), 0 descendants of its own
- K241722: Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment (2024), 0 descendants of its own

## Indications for use
The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ 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™ is compatible with the implant systems listed in table 1: Table 1. Zimmer Screw-vent 3.5; Zimmer Screw-vent 4.5; Zimmer Screw-vent 5.7; Biomet 3i Certain 3.4; Biomet 3i Certain 4.1; Biomet 3i Certain 5.0; Biomet 3i Certain 6.0; Straumann Standard RN; Straumann Standard WN; Neodent GM; Hiossen ET Mini; Hiossen ET Regular. The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at an 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/K230317
Methodology: https://510kreport.com/methodology