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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
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