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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 K260722
Device Name SureSmile Aligner (ASSY500020)
Applicant
Dentsply Sirona, Inc.
211 W. Philadelphia St.
Suite 60w
York,  PA  17401
Applicant Contact Brianne Yaryan
Correspondent
Dentsply Sirona, Inc.
211 W. Philadelphia St.
Suite 60w
York,  PA  17401
Correspondent Contact Brianne Yaryan
Regulation Number872.5470
Classification Product Code
NXC  
Date Received03/05/2026
Decision Date 04/15/2026
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
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