# K013674: Luxatemp/Luxatemp Solar/Instatemp

- Pathway: 510(k) (Traditional)
- Applicant: Dmg USA, Inc.
- Decided: Jan 24, 2002 after 78 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 K924830 (1994). 3 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 15 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) Summary page 1.
- K944981: 3M Tempcare Light Cure Temporary System, 3M Company (1994) Summary page 1.
- K011211: Flowable Composite/ Ecuflow/ Luxaflow, Dmg USA, Inc. (2001)

## Most influential descendants
- K101710: Luxatemp Ultra /Star (2010), 7 descendants of its own
- K073296: TEMPXN28 (2008), 4 descendants of its own
- K200039: P pro Crown & Bridge (2020), 1 descendant of its own
- K251271: TempFIT Temporary Crown and Bridge Resin (2025), 0 descendants of its own
- K243370: DentaTOOTH (2025), 0 descendants of its own

## Indications for use
Luxatemp / InstaTemp are self-cure provisional crown and bridge composites for use in temporary crowns and bridges, long-term temporaries, inlays and onlays. Luxatemp Solar is a dual-cure provisional crown and bridge composite for use in temporary crowns and bridges, long-term temporaries, inlays and onlays. Luxatemp / Luxatemp Solar / InstaTemp are also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture or partial denture.

Source page: https://510kreport.com/device/K013674
Methodology: https://510kreport.com/methodology