Identifiers
- 510(k) Number
- K180629 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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).
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DentiqGuide - 3D Industrial Imaging, Co., Ltd. - PDF Catalogs ..., Planning software - Dentiq Guide - 3D Industrial Imaging, Co., Ltd ..., DentiqSolutions, engineered by 3D Industrial Imaging Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180629 | Class II | Active |
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Manufacturer
- Manufacturer
- 3D Industrial Imaging Co., Ltd.
Sources (1)
- FDA 510(k) K180629 24 fields · synced Sep 24, 2026