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510(k) K181721

Ceracell Ortho Foam by Curasan AG — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2018
Date Received
June 29, 2018
Clearance Type
Traditional
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

  • 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)
  • K031651 — MODIFICATION TO CERASORB ORTHO (August 13, 2003)
  • K014156 — CERASORB ORTHO (March 18, 2002)

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