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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K980543
Device Name DENOPTIX BARRIER ENVELOPE (SIZE 0-4)
Applicant
Dentsply Intl.
901 W. Oakton St.
Des Plaines,  IL  60018
Applicant Contact DANIEL P MURPHY
Correspondent
Dentsply Intl.
901 W. Oakton St.
Des Plaines,  IL  60018
Correspondent Contact DANIEL P MURPHY
Regulation Number872.1800
Classification Product Code
EHD  
Date Received02/12/1998
Decision Date 04/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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