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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 K935535
Device Name TYTIN
Applicant
Kerr Corporation (Danbury)
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Applicant Contact LARRY WILLS
Correspondent
Kerr Corporation (Danbury)
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Correspondent Contact LARRY WILLS
Regulation Number872.3070
Classification Product Code
EJJ  
Subsequent Product Codes
DZS   ELY  
Date Received11/16/1993
Decision Date 03/11/1994
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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