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510(k) K120213

ETCH-RITE SUPREME by Pulpdent Corporation — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2012
Date Received
January 24, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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