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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K210259
Device Name Parkell Self-Adhesive Cement
Applicant
Parkell, Inc.
300 Executive Dr.
Edgewood,  NY  11717
Applicant Contact La-Shaunda Joseph
Correspondent
Parkell, Inc.
300 Executive Dr.
Edgewood,  NY  11717
Correspondent Contact La-Shaunda Joseph
Regulation Number872.3275
Classification Product Code
EMA  
Date Received02/01/2021
Decision Date 01/20/2022
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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