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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K993238
Device Name FORTOSS-CEMA
Applicant
Biocomposites, Ltd.
Etruscan St., Etruria
Stoke On Trent,  GB ST1 5PQ
Applicant Contact JS BRATT
Correspondent
Biocomposites, Ltd.
Etruscan St., Etruria
Stoke On Trent,  GB ST1 5PQ
Correspondent Contact JS BRATT
Regulation Number872.3930
Classification Product Code
LYC  
Date Received09/27/1999
Decision Date 01/14/2000
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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