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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 K932379
Device Name ALL-BOND(R) JR.
Applicant
Bisco, Inc.
1500 W. Thorndale Ave.
Itasca,  IL  60143
Applicant Contact KYONG O JOUNG
Correspondent
Bisco, Inc.
1500 W. Thorndale Ave.
Itasca,  IL  60143
Correspondent Contact KYONG O JOUNG
Regulation Number872.3200
Classification Product Code
KLE  
Date Received05/17/1993
Decision Date 07/22/1993
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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