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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instruments, dental hand
510(k) Number K071858
Device Name DENTAL MATRIX BAND
Original Applicant
FLY CAST TECHNOLOGIES, INC.
p.o. box 848
grayslake,  IL  60030
Original Contact michele h vovolka
Regulation Number872.4565
Classification Product Code
DZN  
Date Received07/05/2007
Decision Date 08/31/2007
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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