# K130654: Crystal Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Dental Laboratory Milling Supplies, LLC (Dlms)
- Decided: Sep 24, 2013 after 196 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K920425 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110131: Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative, 3M Espe Dental Products (2011) Summary page 1.
- K122269: Enamic, Vita Zahnfabrik H.Rauter GmbH & Co. (2012) Summary page 1.

## Indications for use
Crystal® Ultra is indicated for use as a dental restoration inctuding inlays, onlays. veneers, crowns and bridges.

Source page: https://510kreport.com/device/K130654
Methodology: https://510kreport.com/methodology