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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
Applicant
Fly Cast Technologies, Inc.
P.O.Box 848
Grayslake,  IL  60030
Applicant Contact MICHELE H VOVOLKA
Correspondent
Fly Cast Technologies, Inc.
P.O.Box 848
Grayslake,  IL  60030
Correspondent Contact MICHELE H VOVOLKA
Regulation Number872.4565
Classification Product Code
DZN  
Date Received07/05/2007
Decision Date 08/31/2007
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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