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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K043472
Device Name MEDIN TECH ZIRCONIA-CP10, SS1000
Applicant
Medin Tech
6644 Abrams
St-Laurent (Pq),  CA H4S 1Y1
Applicant Contact ABDESLAM KASSEH
Correspondent
Medin Tech
6644 Abrams
St-Laurent (Pq),  CA H4S 1Y1
Correspondent Contact ABDESLAM KASSEH
Regulation Number872.6660
Classification Product Code
EIH  
Date Received12/16/2004
Decision Date 01/18/2005
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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