Home / 510(k) Clearances / K112428

510(k) K112428

NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT by Novabone Products, LLC — Product Code LYC

K112428 is an FDA 510(k) premarket notification submitted by Novabone Products, LLC for the device "NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT". The FDA issued a decision of Substantially Equivalent on December 16, 2011. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Novabone Products, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2011
Date Received
August 23, 2011
Clearance Type
Traditional
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 Novabone Products, LLC

  • K242299 — NovaBone Putty - Synthetic Bioactive Bone Graft (September 25, 2024)
  • K240404 — NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) (March 5, 2024)
  • K220498 — NovoGen Wound Matrix (June 9, 2023)
  • K163310 — NovaBone IRM (January 18, 2017)
  • K152071 — NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (August 26, 2015)
  • K142712 — Dental Collagen Wound Dressing (Nova Tape and NovaPlug) (January 8, 2015)
  • K141207 — NOVABONE BIOACTIVE STRIP (October 31, 2014)
  • K140946 — NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE (August 22, 2014)
  • K112773 — NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT (October 14, 2011)
  • K110925 — NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT (July 5, 2011)

Other clearances for product code LYC

  • K253883 — Bonalive Maxillofacial (May 14, 2026)
  • 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)

FDA data resources