# K130643: Acceledent Aura

- Pathway: 510(k) (Special)
- Applicant: Orthoaccel Technologies, Inc.
- Decided: Apr 23, 2013 after 43 days
- Product code: OYH (Orthodontic Vibratory Accessory)
- 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: 2 generations back to K924975 (1993). 2 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K110661: Acceledent, Orthoaccel Technologies, Inc. (2011) Summary page 1.

## Most influential descendants
- 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
- K183018: VPro5 (2019), 0 descendants of its own
- K170093: AcceleDent Optima (2017), 0 descendants of its own

## Indications for use
AcceleDent® Aura is intended for use during orthodontic treatment. it is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.

Source page: https://510kreport.com/device/K130643
Methodology: https://510kreport.com/methodology