# K110661: Acceledent

- Pathway: 510(k) (Traditional)
- Applicant: Orthoaccel Technologies, Inc.
- Decided: Nov 17, 2011 after 254 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: 1 generation back to K924975 (1993). 1 ancestor in all.
6 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)
- K924975: The Orthotrainer, Myofunctional Research Corp. Pty., Ltd. (1993) Summary page 1.

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

## Indications for use
AcceleDent is an orthodontic accessory 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/K110661
Methodology: https://510kreport.com/methodology