# K202963: ELEC Master, ELEC Master Dual

- Pathway: 510(k) (Traditional)
- Applicant: Mgnewton, Ltd.
- Decided: May 5, 2023 after 947 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- 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 K032572 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163131: A-dec NLZ Electric Motor System, Nakanishi, Inc. (2017) Summary page 4.

## Indications for use
ELEC Master & ELEC Master Dual are intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment.

Source page: https://510kreport.com/device/K202963
Methodology: https://510kreport.com/methodology