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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K990650
Device Name CONSEAL F
Applicant
Southern Dental Industries, Inc.
246 First St., Suite 204
San Francisco,  CA  94105
Applicant Contact SAMANTHA J CHEETHAM
Correspondent
Southern Dental Industries, Inc.
246 First St., Suite 204
San Francisco,  CA  94105
Correspondent Contact SAMANTHA J CHEETHAM
Regulation Number872.3765
Classification Product Code
EBC  
Date Received03/01/1999
Decision Date 05/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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