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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 K897027
Device Name TEETHMATE-A
Applicant
Kuraray Co.
200 Park Ave.
New York,  NY  10166
Applicant Contact SHUJI KAWAI
Correspondent
Kuraray Co.
200 Park Ave.
New York,  NY  10166
Correspondent Contact SHUJI KAWAI
Regulation Number872.3765
Classification Product Code
EBC  
Date Received12/18/1989
Decision Date 03/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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