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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K062176
FOIA Releasable 510(k) K062176
Device Name RELIEF ACP ORAL CARE GEL
Applicant
DISCUS DENTAL INC.
8550 HIGUERA ST.
CULVER CITY,  CA  90232
Applicant Contact STEVEN L ZIEMBA
Correspondent
DISCUS DENTAL INC.
8550 HIGUERA ST.
CULVER CITY,  CA  90232
Correspondent Contact STEVEN L ZIEMBA
Regulation Number872.3260
Classification Product Code
LBH  
Date Received07/31/2006
Decision Date 01/10/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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