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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 K073075
Device Name FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS
Applicant
Dentsply International, Inc.
Susquehanna Commerce Ctr., 221
W. Philadelphia St., Suite 60
York,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
Dentsply International, Inc.
Susquehanna Commerce Ctr., 221
W. Philadelphia St., Suite 60
York,  PA  17404
Correspondent Contact HELEN LEWIS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received10/31/2007
Decision Date 03/31/2008
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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