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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K032904
Device Name ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
Applicant
Dentsply Intl.
901 W. Oakton St.
Des Plaines,  IL  60018
Applicant Contact JOHN R MILLER
Correspondent
Dentsply Intl.
901 W. Oakton St.
Des Plaines,  IL  60018
Correspondent Contact JOHN R MILLER
Regulation Number872.6640
Classification Product Code
EIA  
Date Received09/17/2003
Decision Date 10/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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