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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 K101044
Device Name RETRIEVE IMPLANT CEMENT
Applicant
Parkell, Inc.
300 Executive Dr.
Edgewood,  NY  11717
Applicant Contact DANIEL R SCHECHTER
Correspondent
Parkell, Inc.
300 Executive Dr.
Edgewood,  NY  11717
Correspondent Contact DANIEL R SCHECHTER
Regulation Number872.3275
Classification Product Code
EMA  
Date Received04/14/2010
Decision Date 06/10/2010
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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