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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Rotary Bone Cutting
510(k) Number K862110
Device Name OSSEODENT DRILLING SYSTEM
Applicant
Otc/America
37 Walnut St.
Wellesley Hills,  MA  02181
Applicant Contact RALPH GREEN
Correspondent
Otc/America
37 Walnut St.
Wellesley Hills,  MA  02181
Correspondent Contact RALPH GREEN
Regulation Number872.4120
Classification Product Code
KMW  
Date Received06/03/1986
Decision Date 08/07/1986
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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