HIT Clear Aligner
K-Number: K210613 · 2021-06-04
ApplicantCdb Corporation
Decision Date2021-06-04
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
HIT Clear Aligner is a medical device manufactured by Cdb Corporation. It received FDA 510(k) clearance on 2021-06-04 under approval 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. It is manufactured by Cdb Corporation. The 510(k) number is K210613.
When was HIT Clear Aligner approved by the FDA?
HIT Clear Aligner received FDA 510(k) clearance on 2021-06-04, under approval number K210613.
What company makes HIT Clear Aligner?
HIT Clear Aligner is manufactured by Cdb Corporation.
What is the FDA product code for HIT Clear Aligner?
The FDA product code for HIT Clear Aligner is NXC.
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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.