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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Orthodontic
510(k) Number K062732
Device Name TOMAS PIN 6 MM
Applicant
Dentaurum
10 Pheasant Run
Newtown,  PA  18940
Applicant Contact CHARLES R BELL
Correspondent
Dentaurum
10 Pheasant Run
Newtown,  PA  18940
Correspondent Contact CHARLES R BELL
Regulation Number872.3640
Classification Product Code
OAT  
Date Received09/13/2006
Decision Date 10/25/2006
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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