AlignerFlow LC
FDA 510(k) K231817 · Voco GmbH
510(k) numberK231817
Submission
- Device name
- AlignerFlow LC
- Applicant
- Voco GmbH
Cuxhaven, DE - Received
- June 21, 2023
- Decision date
- December 1, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was AlignerFlow LC cleared by the FDA?
AlignerFlow LC (K231817) received a 510(k) decision of Substantially Equivalent on December 1, 2023, 163 days after the submission was received.
What is the product code of K231817?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.