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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 K151332
Device Name Nexus Universal, Nexus Universal Chroma
Applicant
Sybron Dental Specialties
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact COURTNEY CLARK
Correspondent
Sybron Dental Specialties
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact COURTNEY CLARK
Regulation Number872.3275
Classification Product Code
EMA  
Date Received05/19/2015
Decision Date 08/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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