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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 K974105
Device Name KERR COMPOMER
Applicant
Sybron Dental Specialties, Inc.
1717 W Collins Ave.
Orange,  CA  92667
Applicant Contact WENDY A URTEL
Correspondent
Sybron Dental Specialties, Inc.
1717 W Collins Ave.
Orange,  CA  92667
Correspondent Contact WENDY A URTEL
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/31/1997
Decision Date 01/09/1998
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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