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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 K050331
Device Name ADHESIVE 1
Applicant
Southern Dental Industries, Inc.
729 N. Route 83, Suite 315
Bensenville,  IL  60106
Applicant Contact SAMANTHA J CHEETHAM
Correspondent
Southern Dental Industries, Inc.
729 N. Route 83, Suite 315
Bensenville,  IL  60106
Correspondent Contact SAMANTHA J CHEETHAM
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
LBH  
Date Received02/10/2005
Decision Date 03/24/2005
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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