Ez3D-i v4.3

by Ewoosoft Co., Ltd.

Ez3D-i v4.3 is a Class II device made by Ewoosoft Co., Ltd., cleared under FDA 510(k) K163539 on 23 Dec 2016 and listed in FDA GUDID since 13 Feb 2017 (UDI-DI 08800019700067), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08800019700067 UDI-DI	Date13 Feb 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK163539	Date23 Dec 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08800019700067
FDA 510(k) database 510(k) number K163539

Across registries

2 registries list this device

FDA 510(k) K163539 decided 23 Dec 2016 Active
FDA GUDID UDI-DI 08800019700067 listed 13 Feb 2017 Listed

Timeline

2 dated events

23 Dec 2016 Cleared FDA 510(k) K163539
13 Feb 2017 Listed FDA GUDID 08800019700067

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Ez3D-i
Generic name: General-purpose dental x-ray system application software
Model / reference: v4.3

Primary DI / UDI-DI: 08800019700067
510(k) Number: K163539
FDA product code: LLZ
GMDN term: General-purpose dental x-ray system application software

Device class: Class II
Regulation number: 892.2050
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number
Manufacturing date

Other properties (12, all answered No)