Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment (K241722)
Description
Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment by Elos Medtech Pinol A/S, an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241722
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment (K241722) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231307 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | 2023 |
| K230317 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2023 |
| K173961 | Straumann BLX Implant System | Institut Straumann AG | 2018 |
| K151455 | 3Shape Abutment Designer Software | 3Shape A/S | 2016 |
Trace the full predicate network for K241722
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.