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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 K013383
Device Name BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM
Applicant
Biomedical Implant Technology, Inc.
206 King St.
St. Catharines, On,  CA L2R 3J7
Applicant Contact RODNEY J SHAUGHNESSY
Correspondent
Biomedical Implant Technology, Inc.
206 King St.
St. Catharines, On,  CA L2R 3J7
Correspondent Contact RODNEY J SHAUGHNESSY
Regulation Number872.3640
Classification Product Code
DZE  
Date Received10/12/2001
Decision Date 01/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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