# K210940: LuxaPrint Ortho Plus

- Pathway: 510(k) (Traditional)
- Applicant: Dmg Digital Enterprises SE
- Decided: Sep 3, 2021 after 158 days
- Product code: MQC (Mouthguard, Prescription)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924830 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201173: E-Guard, Envisiontec GmbH (2020) Summary page 4.

## Indications for use
Fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and positioners. The product is for use with OLP/ SLA printers that work at wavelengths of 385 nm or 405 nm.

Source page: https://510kreport.com/device/K210940
Methodology: https://510kreport.com/methodology