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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K962885
Device Name SEALEX EXTRA ROOT CANAL SEALER
Applicant
Baladent
1819 S. May St., 2f
Chicago,  IL  60608
Applicant Contact ROBERT W BAUER
Correspondent
Baladent
1819 S. May St., 2f
Chicago,  IL  60608
Correspondent Contact ROBERT W BAUER
Regulation Number872.3820
Classification Product Code
KIF  
Date Received07/24/1996
Decision Date 08/30/1996
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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