# K261327: Elos Accurate Hybrid Base

- Pathway: 510(k) (Traditional)
- Applicant: Elos Medtech Pinol A/S
- Decided: Sep 30, 2026 after 161 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: 21 generations back to K960026 (1996). 322 ancestors in all.
No later device cites it as a predicate yet.
0 of 323 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242025: Elos Accurate® Hybrid Base™, Elos Medtech Pinol A/S (2024) Summary page 5.

## 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 : Table 1: Implant Platform compatibility Platform diameter [mm] Implant Body diameter [mm] Astra Tech EV 3.0 03 03 Astra Tech EV 3.6 03.6 03.6 Astra Tech EV 4.2 04.2 03.6 & 04.2 Astra Tech EV 4.8 04.8 04.2 & 04.8 Astra Tech EV 5.4 05.4 05.4 Biomet 3i Certain 3.4 03.4 03.25 Biomet 3i Certain 4.1 04.1 04 Biomet 3i Certain 5.0 05 05 Biomet 3i Certain 6.0 06 06 Straumann Bone Level NC 03.3 03.3 Straumann Bone Level RC 04.1/04.8 04.1/04.8 Straumann BLX RB/WB 03.4/03.5/04.5 03.5/03.75/04/ 04.5/05/05.5/06.5 Straumann TLX NT 03.5 03.75/04.5 Straumann TLX RT 04.8 03.75/04.5 Straumann TLX WT 06.5 05.5/ 06.5 Neodent GM 03.5/04.5/05.5/0 6.5 03.5/03.75/04/04.3/0 5/0 6/07 MegaGen AnyRidge 03.5/04.0/04.5/05.0/05.5 04.0/04.4/04.9/05.4/05.9/06.4/06.9/07.4/07.9/08.� Zimmer Screw-vent 3.5 03.5 03.7/04.1 Zimmer Screw-vent 4.5 04.5 04.7 Zimmer Screw-vent 5.7 05.7 06.0 Astra Tech 3.0 03 03 Astra Tech 3.5/4.0 03.5/04 03.5/04 Astra Tech 4.5/5.0 04.5/05 04.5/05 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 millinQ machine and associated toolinQ and accessories.

Source page: https://510kreport.com/device/K261327
Methodology: https://510kreport.com/methodology