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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K934596
Device Name BISCO DUO LINK D/C LUTING COMPOSITE
Applicant
BISCO, INC.
1500 W. THORNDALE AVE.
ITASCA,  IL  60143
Applicant Contact KYONG O JOUNG, PH.D
Correspondent
BISCO, INC.
1500 W. THORNDALE AVE.
ITASCA,  IL  60143
Correspondent Contact KYONG O JOUNG, PH.D
Regulation Number872.3200
Classification Product Code
KLE  
Date Received09/24/1993
Decision Date 01/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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