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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K072754
Device Name AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE
Applicant
Axenic Dental, Inc.
259 E. Michigan Ave.
Suite 409
Kalamazoo,  MI  49007
Applicant Contact JOSEPH T SOBOTA
Correspondent
Axenic Dental, Inc.
259 E. Michigan Ave.
Suite 409
Kalamazoo,  MI  49007
Correspondent Contact JOSEPH T SOBOTA
Regulation Number872.4200
Classification Product Code
EFB  
Date Received09/27/2007
Decision Date 01/25/2008
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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