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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K072978
Device Name TENDER ORTHO BOND-ENA BOND-ENA ETCH
Applicant
MICERIUM S.P.A.
VIA MARCONI 83
AVEGNO, GENOA,  IT 16030
Applicant Contact EUGENIO MICELI
Correspondent
MICERIUM S.P.A.
VIA MARCONI 83
AVEGNO, GENOA,  IT 16030
Correspondent Contact EUGENIO MICELI
Regulation Number872.3750
Classification Product Code
DYH  
Date Received10/22/2007
Decision Date 01/17/2008
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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