FDA 510(k)

HIT Clear Aligner

K-Number: K210613 · 2021-06-04

Decision Date2021-06-04

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

HIT Clear Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Cdb Corporation. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K210613. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIT Clear Aligner?

HIT Clear Aligner is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Cdb Corporation. The 510(k) number is K210613.

When did HIT Clear Aligner receive FDA 510(k) clearance?

HIT Clear Aligner received FDA 510(k) clearance on 2021-06-04, under 510(k) number K210613.

Who is the listed applicant for HIT Clear Aligner?

The FDA 510(k) record lists Cdb Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIT Clear Aligner?

The FDA product code for HIT Clear Aligner is NXC.

Other records listing Cdb Corporation 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.

K212173HDH Treatment Planning System K191823Clear-Aligners K160957CDB Self Ligating Bracket 8F

Related Devices (Code: NXC)

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited K250739Primeprint Direct AlignerDreve Dentamid GmbH

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.