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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 K162436
Device Name EndoVac Pure
Applicant
Kerr Corporation
1717 W. Collins Ave
Orange,  CA  92867
Applicant Contact Mohammad Saad Ansari
Correspondent
Sybron Dental Specialties
1717 W. Collins Ave
Orange,  CA  92867
Correspondent Contact Mohammad Saad Ansari
Regulation Number872.4200
Classification Product Code
NYL  
Date Received08/31/2016
Decision Date 12/21/2016
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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