FDA 510(k), K221537, Nightwear Aligners

510(K) Number: K221537
Device Name: Nightwear Aligners
Manufacturer: Ren Menon
Device Classification Name: Aligner, Sequential
Regulation Number: NXC
Classification Product Code: KXA
Date Received: 05/27/2022
Decision Date: 04/05/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental

171 Pages (589 of 760 original pages are fully redacted)