# K071190: Root ZX II

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Aug 17, 2007 after 109 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: 5 generations back to K951425 (1995). 10 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031204: Dentaport ZX, J. Morita USA, Inc. (2003) Summary page 2.
- K063529: Pencure, Model VL-7, J. Morita USA, Inc. (2007) Summary page 2.

## Most influential descendants
- K090925: Multiple (Apex Locator), Model RCM-7 (2009), 2 descendants of its own
- K151274: Dr's Finder (2016), 1 descendant of its own
- K112665: Tri Auto Mini - Endodeontic Treatment Motorized Handpiece (2012), 1 descendant of its own
- K210475: EQ-M (2022), 0 descendants of its own
- K213477: Root ZX3 (2022), 0 descendants of its own

## Indications for use
DP-ZX-VL is a dental device, composed of a "Canal Measurement Module" and "Handpiece / LED Module". The former can measure the length of the root canal. The latter can enlarge the root canal while monitoring the position of the file tip inside the canal, and can be used to polymerize (set) resinous and other materials by light from the Light Cure Handpiece head.

Source page: https://510kreport.com/device/K071190
Methodology: https://510kreport.com/methodology