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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K973667
Device Name VITAPEX PRE-LOADED DENTAL SYRINGE
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 Number872.3820
Classification Product Code
KIF  
Date Received09/25/1997
Decision Date 11/06/1997
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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