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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K910424
Device Name TEETHMATE-F
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 Number872.3275
Classification Product Code
EMA  
Date Received01/30/1991
Decision Date 04/03/1991
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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