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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name crown and bridge, temporary, resin
510(k) Number K033432
Device Name LEXATITE QUICK ACRYLIC
Applicant
IMTEC CORP.
2401 NORTH COMMERCE
ARDMORE,  OK  73401
Applicant Contact BRAD VANCE
Correspondent
IMTEC CORP.
2401 NORTH COMMERCE
ARDMORE,  OK  73401
Correspondent Contact BRAD VANCE
Regulation Number872.3770
Classification Product Code
EBG  
Date Received10/28/2003
Decision Date 01/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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