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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K202629
Device Name Dentsply Sirona Universal Spray Glazes
Applicant
Dentsply Sirona
221 W. Philadelphia St., Suite 60
York,  PA  17404
Applicant Contact Karl Nittinger
Correspondent
Dentsply Sirona
221 W. Philadelphia St., Suite 60
York,  PA  17404
Correspondent Contact Karl Nittinger
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/11/2020
Decision Date 01/20/2021
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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