# K161213: XSmart iQ

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Feb 10, 2017 after 287 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- 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: 3 generations back to K990682 (1999). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103653: E3 Torque Control Motor, Dentsply International, Inc. (2011) Summary page 4.

## Most influential descendants
- K233288: NLZ Built-In Motor System (2024), 0 descendants of its own
- K233117: Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (2024), 0 descendants of its own

## Indications for use
XSmart iQ is a cordless motor hand-piece with torque control used for driving files in both reciprocating and continuous mode during an endodontic procedure.

Source page: https://510kreport.com/device/K161213
Methodology: https://510kreport.com/methodology