Home / 510(k) Clearances / K113282

510(k) K113282

CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO by Riemser Arzeimittel AG — Product Code LYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2012
Date Received
November 7, 2011
Clearance Type
Special
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 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)