# K924975: The Orthotrainer

- Pathway: 510(k) (Traditional)
- Applicant: Myofunctional Research Corp. Pty., Ltd.
- Decided: Jul 8, 1993 after 281 days
- Product code: KMY (Positioner, Tooth, Preformed)
- Device class: 1
- Regulation: 21 CFR 872.5525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K110661: Acceledent (2011), 6 descendants of its own
- K130643: Acceledent Aura (2013), 5 descendants of its own
- K143120: OrthoPulse (2015), 4 descendants of its own
- K153048: AcceleDent Aura (2016), 2 descendants of its own
- K230905: OrthoPulse 2.0E (OPi2E-100) (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K924975
Methodology: https://510kreport.com/methodology