# K153048: AcceleDent Aura

- Pathway: 510(k) (Traditional)
- Applicant: Orthoaccel Technologies, Inc.
- Decided: Jul 8, 2016 after 263 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: 4 generations back to K924975 (1993). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130643: Acceledent Aura, Orthoaccel Technologies, Inc. (2013) Summary page 4.
- K143120: OrthoPulse, Biolux Research, Ltd. (2015) Summary page 4.

## Most influential descendants
- 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 brackets and wires or aligners and helps facilitate minor anterior tooth movement.

Source page: https://510kreport.com/device/K153048
Methodology: https://510kreport.com/methodology