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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K181476
Device Name Prime&Bond active Universal Adhesive
Applicant
Dentsply Sirona
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Applicant Contact Karl Nittinger
Correspondent
Dentsply Sirona
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Correspondent Contact Karl Nittinger
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/05/2018
Decision Date 09/28/2018
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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