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510(k) K082671

HERCULITE ULTRA by Sybron Dental Specialties — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2008
Date Received
September 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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