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510(k) K031651

MODIFICATION TO CERASORB ORTHO by Curasan AG — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2003
Date Received
May 28, 2003
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

Other clearances by Curasan AG

  • K181721 — Ceracell Ortho Foam (September 17, 2018)
  • K160566 — Cerasorb Ortho Foam (December 2, 2016)
  • K111105 — CURASAN OSSEOLIVE DENTAL (December 20, 2012)
  • K103709 — CERACELL DENTAL (March 10, 2011)
  • K102872 — OSBONE DENTAL (January 12, 2011)
  • K100841 — BONEOPTIMIZER (August 19, 2010)
  • K063106 — REVOIS IMPLANT SYSTEM (June 11, 2007)
  • K040216 — CERASORB M ORTHO (March 26, 2004)
  • K014156 — CERASORB ORTHO (March 18, 2002)

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