# K190930: SmarTemp X1

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Sep 5, 2019 after 148 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: 3 generations back to K924830 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101710: Luxatemp Ultra /Star, Dmg USA, Inc. (2010) Summary page 5.

## Indications for use
SmarTemp® X1 is a self-curing composite for the fabrication of temporary crowns and bridges, inlays, onlays and veneers. SmarTemp® X1 is intended for the fabrication of: temporary crowns, bridges, inlays, onlays, long-term temporaries, and temporary veneers.

Source page: https://510kreport.com/device/K190930
Methodology: https://510kreport.com/methodology