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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Caries Detection
510(k) Number K102821
Device Name DISCOVRED
Applicant
Phoenix Dental, Inc.
3452 W. Thompson Rd.
Fenton,  MI  48430
Applicant Contact JEFFREY S COX
Correspondent
Phoenix Dental, Inc.
3452 W. Thompson Rd.
Fenton,  MI  48430
Correspondent Contact JEFFREY S COX
Regulation Number872.1740
Classification Product Code
LFC  
Date Received09/28/2010
Decision Date 03/11/2011
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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