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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, dental
510(k) Number K041474
Device Name MAXCEM
Applicant
SYBRON DENTAL SPECIALTIES, INC.
1717 W. COLLINS AVE.
ORANGE,  CA  92867
Applicant Contact COLLEEN BOSWELL
Correspondent
SYBRON DENTAL SPECIALTIES, INC.
1717 W. COLLINS AVE.
ORANGE,  CA  92867
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.3275
Classification Product Code
EMA  
Subsequent Product Code
KLE  
Date Received06/02/2004
Decision Date 07/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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