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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Amalgam
510(k) Number K801639
Device Name PERMITE DENTAL AMALGAM ALLOY
Applicant
Southern Dental Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Southern Dental Industries, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received07/17/1980
Decision Date 08/27/1980
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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