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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 K992610
Device Name GENDEX 765DC, MODEL 110-0154
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 Received08/04/1999
Decision Date 09/07/1999
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
Recalls CDRH Recalls
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