EzDent-i v2.1

by Ewoosoft Co., Ltd.

EzDent-i v2.1 is a Class II device made by Ewoosoft Co., Ltd., cleared under FDA 510(k) K161117 on 13 May 2016 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 08800019700005), 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	Number08800019700005 UDI-DI	Date19 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK161117	Date13 May 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08800019700005
FDA 510(k) database 510(k) number K161117

Across registries

2 registries list this device

FDA 510(k) K161117 decided 13 May 2016 Active
FDA GUDID UDI-DI 08800019700005 listed 19 Sep 2016 Listed

Timeline

2 dated events

13 May 2016 Cleared FDA 510(k) K161117
19 Sep 2016 Listed FDA GUDID 08800019700005

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Withdrawn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: v2.1

Primary DI / UDI-DI: 08800019700005
510(k) Number: K161117
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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See all devices from Ewoosoft Co., Ltd. →

Properties

Prescription use
Lot / batch number
Manufacturing date

Other properties (12, all answered No)