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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, Root Canal Irrigation
510(k) Number K100606
Device Name VATEA ENDONTIC IRRIGATION SYSTEM
Applicant
Redent Nova, Ltd.
Columbia Square
555 13th St. NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Redent Nova, Ltd.
Columbia Square
555 13th St. NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number872.4200
Classification Product Code
NYL  
Date Received03/03/2010
Decision Date 05/28/2010
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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