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510(k) K113711

LIME-LITE II by Pulpdent Corporation — Product Code EJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2012
Date Received
December 19, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Liner, Cavity, Calcium Hydroxide
Device Class
Class II
Regulation Number
872.3250
Review Panel
DE
Submission Type

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