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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K091647
Device Name INJECTAFIL
Applicant
Apex Dental Materials, Inc.
330 Telser Rd.
Lake Zurich,  IL  60047
Applicant Contact CHRIS KULTON
Correspondent
Apex Dental Materials, Inc.
330 Telser Rd.
Lake Zurich,  IL  60047
Correspondent Contact CHRIS KULTON
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
KLE  
Date Received06/09/2009
Decision Date 09/21/2009
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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