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Ez3D-i v5.2

by Ewoosoft Co., Ltd.

Ez3D-i v5.2 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Ewoosoft Co., Ltd., cleared under FDA 510(k) K200178 on 25 Feb 2020 and listed in FDA GUDID since 25 Nov 2020 (UDI-DI 08800019700173), 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

510(k) K200178

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800019700173 UDI-DI Date25 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK200178 Date25 Feb 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200178 decided 25 Feb 2020 Active
  • FDA GUDID UDI-DI 08800019700173 listed 25 Nov 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200178
  2. Listed FDA GUDID 08800019700173

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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
v5.2
Primary DI / UDI-DI
08800019700173
510(k) Number
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

Related devices

Category: General-purpose dental x-ray system application software

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)