# K191919: Elos Accurate Hybrid Base

- Pathway: 510(k) (Traditional)
- Applicant: Elos Medtech Pinol A/S
- Decided: Feb 10, 2020 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: 17 generations back to K960026 (1996). 318 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 330 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173908: DESS Dental Smart Solutions, Terrats Medical SL (2018) Summary page 4.

## Most influential descendants
- K201860: Elos Accurate Hybrid Base (2021), 10 descendants of its own
- K230317: Elos Accurate Hybrid Base (2023), 4 descendants of its own
- K222215: IPD Dental Implant Abutments (2022), 4 descendants of its own
- K231413: IPD Dental Implant Abutments (2023), 3 descendants of its own
- K242025: Elos Accurate® Hybrid Base™ (2024), 2 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 the included 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. 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 3.0 — 3 — 3 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 3.0 — 3 — 3 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 All digitally designed zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility.

Source page: https://510kreport.com/device/K191919
Methodology: https://510kreport.com/methodology