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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coating, Filling Material, Resin
510(k) Number K080549
Device Name DURAFINISH ALL-CURE, MODEL S296
Applicant
Parkell, Inc.
300 Executive Dr.
Edgewood,  NY  11717
Applicant Contact DANIEL R SCHECHTER, ESQ
Correspondent
Parkell, Inc.
300 Executive Dr.
Edgewood,  NY  11717
Correspondent Contact DANIEL R SCHECHTER, ESQ
Regulation Number872.3310
Classification Product Code
EBD  
Date Received02/27/2008
Decision Date 05/13/2008
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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