EzDent-i v3.1

by Ewoosoft Co., Ltd.

EzDent-i v3.1 is a Class II device made by Ewoosoft Co., Ltd., cleared under FDA 510(k) K202116 on 21 Aug 2020 and listed in FDA GUDID since 14 Sep 2020 (UDI-DI 08800019700197), 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	Number08800019700197 UDI-DI	Date14 Sep 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK202116	Date21 Aug 2020Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08800019700197
FDA 510(k) database 510(k) number K202116

Across registries

2 registries list this device

FDA 510(k) K202116 decided 21 Aug 2020 Active
FDA GUDID UDI-DI 08800019700197 listed 14 Sep 2020 Listed

Timeline

2 dated events

21 Aug 2020 Cleared FDA 510(k) K202116
14 Sep 2020 Listed FDA GUDID 08800019700197

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: EzDent-i
Generic name: General-purpose dental x-ray system application software
Model / reference: v3.1

Primary DI / UDI-DI: 08800019700197
510(k) Number: K202116
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

Other devices from Ewoosoft Co., Ltd.

EzOrtho

Class IIa
Prora View

Class IIa
Ez3D-i 5.5

Class II
EzDent-i v2.1

Class II

See all devices from Ewoosoft Co., Ltd. →

Properties

Prescription use
Lot / batch number
Manufacturing date

Other properties (12, all answered No)