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FDA 510(k), K221537, Nightwear Aligners
FDA 510(k), K221537, Nightwear Aligners
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$149.00 USD
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510(K) Number: K221537
Device Name: Nightwear Aligners
Manufacturer: Ren Menon
Device Classification Name: Aligner, Sequential
Regulation Number: NXC
Classification Product Code: 05/27/2022
Date Received: 04/05/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: Nightwear Aligners
Manufacturer: Ren Menon
Device Classification Name: Aligner, Sequential
Regulation Number: NXC
Classification Product Code: 05/27/2022
Date Received: 04/05/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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