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510(k) K071452

FL BOND II by Shofu Dental Corp. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2007
Date Received
May 25, 2007
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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  • K080517 — RESICEM (June 11, 2008)
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  • K080068 — BEAUTIFIL OPAQUER (February 28, 2008)

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