# K170093: AcceleDent Optima

- Pathway: 510(k) (Traditional)
- Applicant: Orthoaccel Technology, Inc.
- Decided: May 26, 2017 after 135 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: 5 generations back to K924975 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153048: AcceleDent Aura, Orthoaccel Technologies, Inc. (2016) Summary page 4.

## Indications for use
AcceleDent® Optima 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/K170093
Methodology: https://510kreport.com/methodology