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510(k) K111105

CURASAN OSSEOLIVE DENTAL by Curasan AG — Product Code LYC

K111105 is an FDA 510(k) premarket notification submitted by Curasan AG for the device "CURASAN OSSEOLIVE DENTAL". The FDA issued a decision of Substantially Equivalent on Dec 20, 2012. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Curasan AG has 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 20, 2012
Date Received
Apr 20, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Grafting Material, Synthetic
Device Class
Class II
Regulation Number
872.3930
Review Panel
DE
Submission Type
510(k)

A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.

Other clearances by Curasan AG

  • K181721 — Ceracell Ortho Foam (Sep 17, 2018)
  • K160566 — Cerasorb Ortho Foam (Dec 2, 2016)
  • K103709 — CERACELL DENTAL (Mar 10, 2011)
  • K102872 — OSBONE DENTAL (Jan 12, 2011)
  • K100841 — BONEOPTIMIZER (Aug 19, 2010)
  • K063106 — REVOIS IMPLANT SYSTEM (Jun 11, 2007)
  • K040216 — CERASORB M ORTHO (Mar 26, 2004)
  • K031651 — MODIFICATION TO CERASORB ORTHO (Aug 13, 2003)
  • K014156 — CERASORB ORTHO (Mar 18, 2002)

Other clearances for product code LYC

  • K253317 — Cytrans™ Elashield (Jul 6, 2026)
  • K253883 — Bonalive Maxillofacial (May 14, 2026)
  • K251818 — BONTREE PLUS (Mar 6, 2026)
  • K244006 — FG Bone Graft M (Sep 17, 2025)
  • K243745 — FG Bone Graft B (Aug 29, 2025)
  • K241186 — Synthetic Bone Graft Particulate (Feb 21, 2025)
  • K213260 — CMFlexTM (Dec 30, 2022)
  • K202675 — InRoad® Dental Synthetic Bone Graft (Mar 4, 2022)
  • K201546 — OsOpia Synthetic Bone Void Filler (Oct 2, 2020)
  • K201051 — Straumann BoneCeramic (Sep 24, 2020)

FDA data resources