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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File, Margin Finishing, Operative
510(k) Number K830764
Device Name FR ROOT CANAL SEALER
Applicant
Shizai Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Shizai Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.4565
Classification Product Code
EKA  
Date Received03/10/1983
Decision Date 07/26/1983
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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