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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 K111185
Device Name RELYX LUTING PLUS AUTOMIX
Original Applicant
3M ESPE DENTAL PRODUCTS
3m center, building 260-2a-11
st. paul,  MN  55144 1000
Original Contact bernardo medellin, j.d.
Regulation Number872.3275
Classification Product Code
EMA  
Date Received04/27/2011
Decision Date 05/05/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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