510(k) K111105

CURASAN OSSEOLIVE DENTAL by Curasan AG — Product Code LYC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 20, 2012
Date Received: April 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

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 (September 17, 2018)
K160566 — Cerasorb Ortho Foam (December 2, 2016)
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)

Other clearances for product code LYC

K251818 — BONTREE PLUS (March 6, 2026)
K244006 — FG Bone Graft M (September 17, 2025)
K243745 — FG Bone Graft B (August 29, 2025)
K241186 — Synthetic Bone Graft Particulate (February 21, 2025)
K213260 — CMFlexTM (December 30, 2022)
K202675 — InRoad® Dental Synthetic Bone Graft (March 4, 2022)
K201546 — OsOpia Synthetic Bone Void Filler (October 2, 2020)
K201051 — Straumann BoneCeramic (September 24, 2020)
K192597 — Cytrans Granules (August 17, 2020)
K153676 — OSTEON III (September 14, 2016)