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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K001640
Device Name BIOSOFT RESIN
Applicant
Biosoft International Corp.
944 Williams St.
Trenton,  NJ  08610
Applicant Contact ROY SHU
Correspondent
Biosoft International Corp.
944 Williams St.
Trenton,  NJ  08610
Correspondent Contact ROY SHU
Regulation Number872.3760
Classification Product Code
EBI  
Date Received05/08/2000
Decision Date 06/23/2000
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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