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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 K892861
Device Name DENTAL PIK
Applicant
U.S. Dentek Corp.
32 Leveroni Ct.
#101
Novato,  CA  94949
Applicant Contact JOHN M JANSHESKI
Correspondent
U.S. Dentek Corp.
32 Leveroni Ct.
#101
Novato,  CA  94949
Correspondent Contact JOHN M JANSHESKI
Regulation Number872.4565
Classification Product Code
EKS  
Date Received04/18/1989
Decision Date 09/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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