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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 K012681
Device Name ANKYLOS
Applicant
Dentsply Ceramco
Six Terri Ln.
Suite 100
Burlington,  NJ  08016
Applicant Contact THOMAS B CAMERON
Correspondent
Dentsply Ceramco
Six Terri Ln.
Suite 100
Burlington,  NJ  08016
Correspondent Contact THOMAS B CAMERON
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/14/2001
Decision Date 08/22/2003
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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