# K013179: Luxaglaze

- Pathway: 510(k) (Traditional)
- Applicant: Dmg USA, Inc.
- Decided: Oct 12, 2001 after 18 days
- Product code: EBD (Coating, Filling Material, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3310
- 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 K992067 (1999). 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)
- K992067: Belleglaze, Kerr Dental Materials Center (1999) Summary page 1.

## Indications for use
LuxaGlaze is a light-cure one-bottle varnish for glazing the surfaces of provisional crowns, bridges and custom trays.

Source page: https://510kreport.com/device/K013179
Methodology: https://510kreport.com/methodology