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510(k) K123615

IRIS - HIGH STRENGTH GLASS CERAMIC by Dentsply Intl. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2013
Date Received
November 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

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