FDA 510(k)

Dentiq3D

K-Number: K160666 · 2016-10-05

Applicant3D Industrial Imaging Co., Ltd.

Decision Date2016-10-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Dentiq3D 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 2016-10-05 under 510(k) number K160666. 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 Dentiq3D?

Dentiq3D is a medical device that received FDA 510(k) clearance on 2016-10-05. The listed applicant is 3D Industrial Imaging Co., Ltd.. The 510(k) number is K160666.

When did Dentiq3D receive FDA 510(k) clearance?

Dentiq3D received FDA 510(k) clearance on 2016-10-05, under 510(k) number K160666.

Who is the listed applicant for Dentiq3D?

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 Dentiq3D?

The FDA product code for Dentiq3D 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.

K200078VARO Plan K183676DentiqAir K180629DentiqGuide

Related Devices (Code: LLZ)

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

Official Source

View on FDA Database →

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