# K210475: EQ-M

- Pathway: 510(k) (Traditional)
- Applicant: Meta Systems Co., Ltd.
- Decided: Sep 21, 2022 after 581 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- 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: 7 generations back to K951425 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112665: Tri Auto Mini - Endodeontic Treatment Motorized Handpiece, J. Morita USA, Inc. (2012) Summary page 4.

## Indications for use
The EQ-M motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points. When connected to Apex locator (EQ-PEX), the EQ-M can be used to measure the length of root canals.

Source page: https://510kreport.com/device/K210475
Methodology: https://510kreport.com/methodology