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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K062409
Device Name K-ETCHANT GEL
Applicant
Kuraray Medical, Inc.
600 Lexington Ave. 26th Floor
New York,  NY  10022
Applicant Contact KOJI NISHIDA
Correspondent
Kuraray Medical, Inc.
600 Lexington Ave. 26th Floor
New York,  NY  10022
Correspondent Contact KOJI NISHIDA
Regulation Number872.3690
Classification Product Code
EBF  
Date Received08/17/2006
Decision Date 11/08/2006
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
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