FDA 510(k) K230199, Byte Aligner System, by Dentsply Sirona, Inc.
FDA 510(k) K230199, Byte Aligner System, by Dentsply Sirona, Inc.
Device Classification Name: Aligner, Sequential
510(k) Number: K230199
Device Name: Byte Aligner System
Applicant: Dentsply Sirona, Inc.
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 01/25/2023
Decision Date: 10/18/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
510k Review Panel: Dental
Total number of pages: 974
Fully redacted pages: 408
Content pages: 566
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