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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 K012737
Device Name CHROMA ZONE COLOR STAIN
Applicant
Kuraray Medical, Inc.
30th Floor Metlife Bldg.
200 Park Ave.
New York,  NY  10166
Applicant Contact MASAYA SASAKI
Correspondent
Kuraray Medical, Inc.
30th Floor Metlife Bldg.
200 Park Ave.
New York,  NY  10166
Correspondent Contact MASAYA SASAKI
Regulation Number872.3690
Classification Product Code
EBF  
Date Received08/14/2001
Decision Date 09/14/2001
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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