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VARO Plan 1.0

by 3D Industrial Imaging Co., Ltd.

VARO Plan 1.0 is a dental treatment application software (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by 3D Industrial Imaging Co., Ltd., cleared under FDA 510(k) K200078 on 10 Apr 2020 and listed in FDA GUDID since 29 Dec 2020 (UDI-DI 08800022900089), 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) K200078

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 Number08800022900089 UDI-DI Date29 Dec 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200078 Date10 Apr 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200078 decided 10 Apr 2020 Active
  • FDA GUDID UDI-DI 08800022900089 listed 29 Dec 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200078
  2. Listed FDA GUDID 08800022900089

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
VARO Plan
Generic name
Dental treatment application software
Model / Ref / Catalog
1.0
Primary DI / UDI-DI
08800022900089
510(k) Number
FDA product code
LLZ
GMDN term
Dental treatment application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Other devices from 3D Industrial Imaging Co., Ltd.

  • Dentiq3D 1.0

    Class II
  • DentiqAir 1.0

    Class II
  • DentiqGuide 1.0

    Class II
  • VARO Plan

    Class II

See all devices from 3D Industrial Imaging Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)