FDA 510(k)

DentiqGuide

K-Number: K180629 · 2018-07-19

Applicant3D Industrial Imaging Co., Ltd.

Decision Date2018-07-19

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DentiqGuide is the device name listed in this FDA 510(k) record. The listed applicant is 3D Industrial Imaging Co., Ltd.. It received FDA 510(k) clearance on 2018-07-19 under 510(k) number K180629. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DentiqGuide?

DentiqGuide is a medical device that received FDA 510(k) clearance on 2018-07-19. The listed applicant is 3D Industrial Imaging Co., Ltd.. The 510(k) number is K180629.

When did DentiqGuide receive FDA 510(k) clearance?

DentiqGuide received FDA 510(k) clearance on 2018-07-19, under 510(k) number K180629.

Who is the listed applicant for DentiqGuide?

The FDA 510(k) record lists 3D Industrial Imaging Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DentiqGuide?

The FDA product code for DentiqGuide is LLZ.

Other records listing 3D Industrial Imaging Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.