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510(k) K111185

RELYX LUTING PLUS AUTOMIX by 3M Espe Dental Products — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2011
Date Received
April 27, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

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