# K251701: Star E900 Electric System

- Pathway: 510(k) (Traditional)
- Applicant: Dentalez, Inc., Stardental Division
- Decided: Jan 12, 2026 after 224 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: 6 generations back to K970339 (1997). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163402: NLZ Motor System, Nakanishi, Inc. (2017) Summary page 5.

## Indications for use
The Star E900 Electric System is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.

Source page: https://510kreport.com/device/K251701
Methodology: https://510kreport.com/methodology