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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K883465
Device Name ORTHO-SEAL
Applicant
BISCO, INC.
3010-J WOODCREEK DR.
DOWNERS GROVE,  IL  60515 -5409
Applicant Contact BYOUNG I SUH
Correspondent
BISCO, INC.
3010-J WOODCREEK DR.
DOWNERS GROVE,  IL  60515 -5409
Correspondent Contact BYOUNG I SUH
Regulation Number872.3750
Classification Product Code
DYH  
Date Received08/15/1988
Decision Date 10/12/1988
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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