# K183337: LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2

- Pathway: 510(k) (Traditional)
- Applicant: DMG Chemisch-Pharmazeutische Fabrik GmbH
- Decided: May 29, 2019 after 177 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- 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 K924830 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180562: Temp Basic, Temp Premium, Temp Premium Flexible, Multistratum Flexible, Therapon, Try-in, Burnout, Try-in & Burnout, Zirkonzahn GmbH (2018) Summary page 5.

## Indications for use
LuxaCrown is a self-curing composite for the fabrication of semi-permanent crowns and bridges. The material is mixed automatically. Specifically: Crown restorations: • For restoration of the anatomical form in order to provide durable protection for the remaining tooth • In order to restore chewing function • For esthetic corrections Bridge restorations: • In order to restore chewing function • For esthetic corrections

Source page: https://510kreport.com/device/K183337
Methodology: https://510kreport.com/methodology