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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File, Pulp Canal, Endodontic
510(k) Number K062856
Device Name TF ROTARY NICKEL TITANIUM FILE
Applicant
Ormco Corp.
100 Bayview Cir.
Suite 6000
Newport Beach,  CA  92660
Applicant Contact COLLEEN BOSWELL
Correspondent
Ormco Corp.
100 Bayview Cir.
Suite 6000
Newport Beach,  CA  92660
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.4565
Classification Product Code
EKS  
Date Received09/25/2006
Decision Date 12/13/2006
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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