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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, Root-Form
510(k) Number K860653
Device Name PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT
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 Number872.3640
Classification Product Code
DZE  
Date Received02/21/1986
Decision Date 04/17/1986
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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