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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K100212
Device Name DENTACENTER/EXPEDITION, MODEL SAF-430
Applicant
Safari Dental, Inc.
94 D Enterprises Boul.
Boisbriand, Quebec,  CA J7G 2T3
Applicant Contact ANDRE MATHIEU
Correspondent
Safari Dental, Inc.
94 D Enterprises Boul.
Boisbriand, Quebec,  CA J7G 2T3
Correspondent Contact ANDRE MATHIEU
Regulation Number872.6640
Classification Product Code
EIA  
Date Received01/25/2010
Decision Date 10/22/2010
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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