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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K053329
Device Name KORLEX-GR GINGIVAL RETRACTION PASTE
Applicant
Biotech One, Inc.
92 Costa Brava
Laguna Niguel,  CA  92677
Applicant Contact KAREN UYESUGI
Correspondent
Biotech One, Inc.
92 Costa Brava
Laguna Niguel,  CA  92677
Correspondent Contact KAREN UYESUGI
Classification Product Code
MVL  
Date Received12/01/2005
Decision Date 02/15/2006
Decision Substantially Equivalent (SESE)
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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