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510(k) K023742

SCULPTURE PLUS NANO-HYBRID COMPOSITE by Pentron Laboratory Technologies — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2003
Date Received
November 7, 2002
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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