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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K012405
Device Name EXTRUDE MODIFIED
Applicant
Sybron Dental Specialties, Inc.
1717 W Collins Ave.
Orange,  CA  92667
Applicant Contact COLLEEN BOSWELL
Correspondent
Sybron Dental Specialties, Inc.
1717 W Collins Ave.
Orange,  CA  92667
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.3660
Classification Product Code
ELW  
Date Received07/30/2001
Decision Date 09/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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