FDA 510(k)

DentiqAir

K-Number: K183676 · 2019-12-19

Applicant3D Industrial Imaging Co., Ltd.

Decision Date2019-12-19

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DentiqAir 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 2019-12-19 under 510(k) number K183676. 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 DentiqAir?

DentiqAir is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is 3D Industrial Imaging Co., Ltd.. The 510(k) number is K183676.

When did DentiqAir receive FDA 510(k) clearance?

DentiqAir received FDA 510(k) clearance on 2019-12-19, under 510(k) number K183676.

Who is the listed applicant for DentiqAir?

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 DentiqAir?

The FDA product code for DentiqAir 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.