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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K150559
Device Name Life Fast Set, Life Regular Set
Applicant
Sybron Dental Specialties
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact Kerri Casino
Correspondent
Sybron Dental Specialties
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact Kerri Casino
Regulation Number872.3250
Classification Product Code
EJK  
Date Received03/06/2015
Decision Date 06/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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