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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K060946
Device Name CZ-S2000
Applicant
Parkell, Inc.
300 Executive Dr.
Edgewood,  NY  11717
Applicant Contact NELSON J GENDUSA
Correspondent
Parkell, Inc.
300 Executive Dr.
Edgewood,  NY  11717
Correspondent Contact NELSON J GENDUSA
Regulation Number872.3820
Classification Product Code
KIF  
Date Received04/06/2006
Decision Date 06/15/2006
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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