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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K102917
Device Name FIXTEMP C&B
Applicant
Exacta Dental Direct, Inc.
1151 Hope St.
Stamford,  CT  06907
Applicant Contact RICHARD KEEN
Correspondent
Exacta Dental Direct, Inc.
1151 Hope St.
Stamford,  CT  06907
Correspondent Contact RICHARD KEEN
Regulation Number872.3770
Classification Product Code
EBG  
Date Received10/01/2010
Decision Date 06/17/2011
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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