# K091065: Air Torx, Model  Tra-200, Tra-200-CP3, Tra-200-CP4

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Oct 16, 2009 after 185 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- 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 K944713 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944713: W&H Micro Air Motor LT25, A-Dec, Inc. (1995) Summary page 2.

## Indications for use
AIR TORX is used as a motor to drive attachments by air supplied from the treatment unit's air supply system. Attachments are geared handpieces that are used to drill and polish teeth.

Source page: https://510kreport.com/device/K091065
Methodology: https://510kreport.com/methodology