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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 K061337
Device Name WIEDENT ESTETIC
Applicant
Xpdent Corp
12145 SW 131st Ave.
Miami,  FL  33186
Applicant Contact CARMEN PEREZ
Correspondent
Xpdent Corp
12145 SW 131st Ave.
Miami,  FL  33186
Correspondent Contact CARMEN PEREZ
Regulation Number872.3590
Classification Product Code
ELM  
Date Received05/12/2006
Decision Date 06/07/2006
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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