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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K243336
Device Name Lucitone Digital Print Denture™ System
Applicant
Dentsply Sirona, Inc.
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Applicant Contact Melanie Avila
Correspondent
Dentsply Sirona, Inc.
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Correspondent Contact Melanie Avila
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Codes
EBD   EBG   KLE   PZY  
Date Received10/24/2024
Decision Date 12/17/2024
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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