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510(k) K100841

BONEOPTIMIZER by Curasan AG — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2010
Date Received
March 25, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

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  • K103709 — CERACELL DENTAL (March 10, 2011)
  • K102872 — OSBONE DENTAL (January 12, 2011)
  • K063106 — REVOIS IMPLANT SYSTEM (June 11, 2007)
  • K040216 — CERASORB M ORTHO (March 26, 2004)
  • K031651 — MODIFICATION TO CERASORB ORTHO (August 13, 2003)
  • K014156 — CERASORB ORTHO (March 18, 2002)

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