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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K870209
Device Name NEXADENT (DENTAL CEMENT)
Applicant
Bionexus, Inc.
5257 N. Blvd.
P.O. Drawer 58517
Raleigh,  NC  27658
Applicant Contact CHARLES R DESMET
Correspondent
Bionexus, Inc.
5257 N. Blvd.
P.O. Drawer 58517
Raleigh,  NC  27658
Correspondent Contact CHARLES R DESMET
Regulation Number872.3275
Classification Product Code
EMA  
Date Received01/20/1987
Decision Date 02/19/1987
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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