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FDA 510(k)

AlignerFlow LC

K-Number: K231817 · 2023-12-01

ApplicantVoco GmbH
Decision Date2023-12-01
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AlignerFlow LC is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K231817. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AlignerFlow LC?

AlignerFlow LC is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Voco GmbH. The 510(k) number is K231817.

When did AlignerFlow LC receive FDA 510(k) clearance?

AlignerFlow LC received FDA 510(k) clearance on 2023-12-01, under 510(k) number K231817.

Who is the listed applicant for AlignerFlow LC?

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

What is the FDA product code for AlignerFlow LC?

The FDA product code for AlignerFlow LC is DYH.

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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.

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