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DentiqGuide

by 3D Industrial Imaging Co., Ltd.

510(k) K180629

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK180629 Date19 Jul 2018ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LLZ
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

DentiqGuide is a planning software for digital dentistry, designed for prosthetic-driven planning, surgical guide fabrication, and comprehensive treatment workflows. It is a cloud-based system provided by 3D Industrial Imaging Co., Ltd.

The device is supplied as software and is used in dental treatment planning and surgical guide design. It received FDA 510(k) clearance (K180629) on July 19, 2018, and is classified under product code LLZ with advisory committee review in Radiology (RA).

Devices cleared under K180629

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K180629
UDI-DISize and differences
DentiqGuide 1.0
3D Industrial Imaging Co., Ltd.
1.008800022900041 —On the market

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

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

  • VARO Plan 1.0

    Class II

  • Dentiq3D 1.0

    Class II

  • DentiqAir 1.0

    Class II

  • DentiqGuide 1.0

    Class II

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