# K033227: Luxaform Plus

- Pathway: 510(k) (Traditional)
- Applicant: Dmg USA, Inc.
- Decided: Jan 16, 2004 after 102 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: 1 generation back to K900389 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000951: Luxaform, Dmg USA, Inc. (2000) Summary page 1.
- K900389: Temporary Crown Matrix Buttons, Advantage Dental Products, Inc. (1990) Summary page 1.
- K915898: Paladur, Heraeus Kulzer, Inc. (1992) Summary page 1.

## Indications for use
LuxaForm Plus is indicated for the following uses: * As a matrix in the fabrication of provisional dental crowns and bridges * Mini "custom tray" for impressions * Articulation of diagnostic molds * Articulation of the working cast against the opposing arch · For fabrication of a maxillary bite guard, a maxillary anterior or posterior bite plate or a maxillary anterior repositioning appliance * Direct fabrication of Maxillary sports guard in the mouth without models * Bite registration material either to be used directly or in combination with three way trays (e.g. Triple Trays from Premier) · Reinforcement of three way trays · For use in functional therapeutic cases as e.g. a Lucia Jig, anterior repositioning splint etc. · Guiding matrix to help recreate anatomic form

Source page: https://510kreport.com/device/K033227
Methodology: https://510kreport.com/methodology