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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 K050604
Device Name KERR VPS IMPRESSION MATERIAL
Applicant
SYBRON DENTAL SPECIALTIES, INC.
1717 W. COLLINS AVENUE
ORANGE,  CA  92867
Applicant Contact COLLEEN BOSWELL
Correspondent
SYBRON DENTAL SPECIALTIES, INC.
1717 W. COLLINS AVENUE
ORANGE,  CA  92867
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.3660
Classification Product Code
ELW  
Date Received03/09/2005
Decision Date 04/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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