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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K230199
Device Name Byte Aligner System
Applicant
Dentsply Sirona, Inc.
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Applicant Contact Sobrin Laura
Correspondent
Dentsply Sirona, Inc.
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Correspondent Contact Sobrin Laura
Regulation Number872.5470
Classification Product Code
NXC  
Date Received01/25/2023
Decision Date 10/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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