# K250739: Primeprint Direct Aligner

- Pathway: 510(k) (Traditional)
- Applicant: Dreve Dentamid GmbH
- Decided: Nov 7, 2025 after 241 days
- Product code: NXC (Aligner, Sequential)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K780619 (1978). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212680: LuxCreo Clear Aligner System, LuxCreo, Inc. (2022) Summary page 5.

## Indications for use
Primeprint Aligner is a light curing resin intended for the treatment of tooth malocclusion in patients with developed permanent dentition. Primeprint Aligner repositions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K250739
Methodology: https://510kreport.com/methodology