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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 K861502
Device Name EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM
Applicant
Dr. Harold Bergman
#200 - 805 W. Broadway
Vancouver, B.C.
Canada,  CA V5Z 1K1
Correspondent
Dr. Harold Bergman
#200 - 805 W. Broadway
Vancouver, B.C.
Canada,  CA V5Z 1K1
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/23/1986
Decision Date 06/26/1986
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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