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Dentiq3D 1.0

by 3D Industrial Imaging Co., Ltd.

Dentiq3D 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) K160666 on 5 Oct 2016 and listed in FDA GUDID since 19 Dec 2016 (UDI-DI 08800022900003), 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) K160666

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 Number08800022900003 UDI-DI Date19 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160666 Date5 Oct 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160666 decided 5 Oct 2016 Active
  • FDA GUDID UDI-DI 08800022900003 listed 19 Dec 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160666
  2. Listed FDA GUDID 08800022900003

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dentiq3D
Generic name
Dental treatment application software
Model / Ref / Catalog
1.0
Primary DI / UDI-DI
08800022900003
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.

  • VARO Plan 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
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)