# K212803: DailyMate Orthodontic Aligner System

- Pathway: 510(k) (Traditional)
- Applicant: 3D Global Biotech, Inc.
- Decided: May 23, 2022 after 263 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: 6 generations back to K780619 (1978). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182329: SureCure Orthodontic Aligner System, Digital Orthodontic Care (2018) Summary page 4.

## Most influential descendants
- K233356: Illusion Aligner Pro: Illusion Aligner FLX (2024), 1 descendant of its own
- K251454: Clear Aligner (SCF-3348) (2026), 0 descendants of its own

## Indications for use
The DailyMate Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The aligner system repositions teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K212803
Methodology: https://510kreport.com/methodology