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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Zinc Oxide Eugenol
510(k) Number K120695
Device Name DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT
Applicant
Dentist IN A Box Pty., Ltd.
44 Horace St.
Malvern, Victoria,  AU 3144
Applicant Contact JOHN BANKY
Correspondent
Dentist IN A Box Pty., Ltd.
44 Horace St.
Malvern, Victoria,  AU 3144
Correspondent Contact JOHN BANKY
Regulation Number872.3275
Classification Product Code
EMB  
Date Received03/07/2012
Decision Date 06/12/2012
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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