# K013236: Luxabite

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Oct 17, 2001 after 19 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924830 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924830: Luxatemp Automix, Dmg Chemisch Pharmazeutische Fabrik GmbH (1994). Our OCR of the scanned summary read K942830, FDA’s number for HAE 3 (Hearing Aid Express). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “LuxaTemp temporary crown and bridge material”.

## Indications for use
LuxaBite is indicated for use as a bite registration material for use in the production of crowns, bridges and dentures, and in orthodontic treatments. It may also be used as a provisional crown & bridge material.

Source page: https://510kreport.com/device/K013236
Methodology: https://510kreport.com/methodology