# K173124: PEEK Biosolution

- Pathway: 510(k) (Traditional)
- Applicant: Merz Dental GmbH
- Decided: Dec 18, 2017 after 80 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K043504 (2005). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152113: BioHPP - breCAM.BioHPP, Bredent GmbH & Co. KG (2016) Summary page 4.

## Indications for use
PEEK Biosolution is intended to be used for the fabrication of permanent dental restorations using CAD/CAM techniques. These are: • Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm² connector cross-section) • Crown copings and bridge substructures for composite veneering (max. 2 pontics and min.13 mm² connector cross-section)) • Telescopic primary and secondary crowns and frameworks • Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide.

Source page: https://510kreport.com/device/K173124
Methodology: https://510kreport.com/methodology