Manufacturer registered with FDA

MGNEWTON Ltd.

Gyengsan-si, South Korea. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10060251Manufacturer2 clearances in five years

Device types listed: 2
Brands and models: 2
510(k) clearances: 22022–2023
Markets registered in: 1United States
Establishments: 1South Korea

510(k) clearances per year, 2007–2026

Devices listed with FDA

What MGNEWTON Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Maker	CURA-Temp	2022
Operative Dental UnitEIA · Class 1	Dental chairs & operative units	Maker	ELEC Master, ELEC Master Dual	2023

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names MGNEWTON Ltd. as the applicant.

Decided	510(k)	Device	Device type
5 May 2023	K202963	ELEC Master, ELEC Master Dual	EIA Operative Dental Unit
21 Dec 2022	K202965	CURA-Temp	EBG Resin Temporary Crown and Bridge

Registered establishments

Establishment	Location	What it does
MGNEWTON LTD.FDA reg. 3015396763	Gyengsan-si Gyeongbuk, South Korea	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10060251). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.