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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 K863028
Device Name ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY
Applicant
Ross Implant Technologies Corp., Inc.
Arent,Fox,Kintner,Plotkin,Kahn
1050 Connecticut Ave., Nw.
Washington,  DC  20036
Applicant Contact W. R PENDERGAST
Correspondent
Ross Implant Technologies Corp., Inc.
Arent,Fox,Kintner,Plotkin,Kahn
1050 Connecticut Ave., Nw.
Washington,  DC  20036
Correspondent Contact W. R PENDERGAST
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/11/1986
Decision Date 10/06/1986
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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