# DentiqGuide

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/dentiqguide-llz>
- Manufacturer: [3D Industrial Imaging Co., Ltd.](https://devicerts.com/manufacturers/3d-industrial-imaging-co-ltd) (South Korea, FDA 510(k) applicant)
- Device class: Class II (US FDA)
- FDA product code: LLZ

## Overview

*AI-generated summary, 2026-09-24. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data 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).

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K180629 · decision 2018-07-19 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K180629 [FDA 510(k)]
- FDA product code: LLZ [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.2050 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: DentiqGuide, 3D Industrial Imaging Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/dentiqguide-llz (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/dentiqguide-llz.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/dentiqguide-llz
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.