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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 K971642
Device Name DENTALIS KEZ ENDODONITC SEALER
Applicant
Neodental Chemical Products Co., Ltd.
7613 Carteret Rd.
Bethesda,  MD  20817
Applicant Contact KYLE H SIBINOVIC
Correspondent
Neodental Chemical Products Co., Ltd.
7613 Carteret Rd.
Bethesda,  MD  20817
Correspondent Contact KYLE H SIBINOVIC
Regulation Number872.3275
Classification Product Code
EMA  
Date Received05/02/1997
Decision Date 07/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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