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510(k) K081287

SAPPHIRE PLASMA ARC DENTAL CURING LIGHT by Den-Mat Holdings, LLC — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2008
Date Received
May 7, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activator, Ultraviolet, For Polymerization
Device Class
Class II
Regulation Number
872.6070
Review Panel
DE
Submission Type

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