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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K041645
Device Name DDS-ZR
Applicant
Charles Scharf
7375 S. Peoria St. #105 B-10
Englewood,  CO  80112
Applicant Contact CHRIS SCHARF
Correspondent
Charles Scharf
7375 S. Peoria St. #105 B-10
Englewood,  CO  80112
Correspondent Contact CHRIS SCHARF
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/17/2004
Decision Date 07/09/2004
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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