# K230644: Signum opaque F

- Pathway: 510(k) (Traditional)
- Applicant: Kulzer, LLC
- Decided: Sep 7, 2023 after 183 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: 5 generations back to K902115 (1990). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152373: VITA VM LC Flow, Vita Zahnfabrik H.Rauter GmbH & Co. (2015) Summary page 4.

## Indications for use
Light curing one-component opaquer to mask framework structures. Signum opaque F is the opaquer component for veneering materials and denture base materials (heat/cold curing denture acrylics) offered by Kulzer.

Source page: https://510kreport.com/device/K230644
Methodology: https://510kreport.com/methodology