# K213477: Root ZX3

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Aug 3, 2022 after 278 days
- Product code: EKZ (Unit, Electrosurgical, And Accessories, Dental)
- Device class: 2
- Regulation: 21 CFR 872.4920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K951425 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071190: Root ZX II, J. Morita USA, Inc. (2007) Summary page 5.
- K020080: Bonart Art-E1 Electrosurgery Unit, Diagnostic Data, Inc. (2002) Summary page 5.

## Indications for use
The Root ZX3 device is a dental device with an apex locating function and an optional electrosurgical function and is composed of the aforementioned corresponding modules. The apex locating function of Root ZX3 device is used for root canal measurement and working length determination. The electrosurgical function is used for the following dental procedures: gingival incision and excision, gingivoplasty, gingivectomy, hemostasis, pulpotomy, pulpotomy as an adjunct to root canal therapy, and excision of intraoral lesions. It is also used for the ablation of pulp, dental filling material (e.g. gutta-percha) and tissue in/around root canals as an adjunct to root canal therapy, after determining the tip position of the active electrode by apex location.

Source page: https://510kreport.com/device/K213477
Methodology: https://510kreport.com/methodology