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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Denture, Plastic, Teeth
510(k) Number K022299
Device Name TRILUX, Z-TONE, ACRY ROCK
Applicant
Ruthibras Imp. Exp. Com. DE Materiais Odontologico
13 Red Fox Ln.
Littleton,  CO  80127
Applicant Contact Kevin Walls
Correspondent
Ruthibras Imp. Exp. Com. DE Materiais Odontologico
13 Red Fox Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number872.3590
Classification Product Code
ELM  
Date Received07/16/2002
Decision Date 10/07/2002
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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