# K101710: Luxatemp Ultra /Star

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Sep 28, 2010 after 103 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: 2 generations back to K924830 (1994). 4 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013674: Luxatemp/Luxatemp Solar/Instatemp, Dmg USA, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K191619: TurboTemp EZ (2019), 0 descendants of its own
- K190930: SmarTemp X1 (2019), 0 descendants of its own

## Indications for use
Luxatemp Ultra/Star is a self-curing or dual-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers. Luxatemp Ultra/Star is intended for the fabrication of: temporary crowns bridges inlays onlays long-term temporaries temporary veneers Luxatemp Ultra/Star is 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/K101710
Methodology: https://510kreport.com/methodology