Argen Clear Aligner
K-Number: K183229 · 2019-06-07
ApplicantArgen Corporation
Decision Date2019-06-07
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Argen Clear Aligner is a medical device manufactured by Argen Corporation. It received FDA 510(k) clearance on 2019-06-07 under approval number K183229. 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 Argen Clear Aligner?
Argen Clear Aligner is a medical device that received FDA 510(k) clearance on 2019-06-07. It is manufactured by Argen Corporation. The 510(k) number is K183229.
When was Argen Clear Aligner approved by the FDA?
Argen Clear Aligner received FDA 510(k) clearance on 2019-06-07, under approval number K183229.
What company makes Argen Clear Aligner?
Argen Clear Aligner is manufactured by Argen Corporation.
What is the FDA product code for Argen Clear Aligner?
The FDA product code for Argen 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.