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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 K231578
Device Name Lucitone Digital Print Denture System
Applicant
Dentsply Sirona
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Applicant Contact Rebecca Sporer
Correspondent
Dentsply Sirona
221 W. Philadelphia St. Suite 60w
York,  PA  17401
Correspondent Contact Rebecca Sporer
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Codes
EBD   KLE   PZY  
Date Received05/31/2023
Decision Date 10/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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