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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K965091
Device Name TEETHMATE F-1
Applicant
Kuraray Company, Ltd.
200 Park Ave.
New York,  NY  10166
Applicant Contact KOJI FUJITA
Correspondent
Kuraray Company, Ltd.
200 Park Ave.
New York,  NY  10166
Correspondent Contact KOJI FUJITA
Regulation Number872.3765
Classification Product Code
EBC  
Date Received12/19/1996
Decision Date 03/27/1997
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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