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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 K881924
Device Name ENDOSSEOUS DENTAL IMPLANT
Applicant
Bone Anchorage Systems, Inc.
298 Kennedy Ave.
Toronto, Canada,  CA M6P 3C3
Applicant Contact ROSS PERRY
Correspondent
Bone Anchorage Systems, Inc.
298 Kennedy Ave.
Toronto, Canada,  CA M6P 3C3
Correspondent Contact ROSS PERRY
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/09/1988
Decision Date 06/13/1988
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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