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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wax, Dental, Intraoral
510(k) Number K020009
Device Name BRACE EZE
Applicant
Udent, Inc.
676 Fairplex Dr.
Pomona,  CA  91768
Applicant Contact MANAR JAMAL
Correspondent
Udent, Inc.
676 Fairplex Dr.
Pomona,  CA  91768
Correspondent Contact MANAR JAMAL
Regulation Number872.6890
Classification Product Code
EGD  
Date Received01/02/2002
Decision Date 02/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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