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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name handpiece, air-powered, dental
510(K) Number K113674
Device Name SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT
Applicant
HANDPIECE HEADQUARTERS INC. - HPR INC.
620 s. placentia ave
placentia,  CA  92870
Contact tina steffanie-oak
Regulation Number872.4200
Classification Product Code
EFB  
Date Received12/14/2011
Decision Date 04/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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