Novabone-Bioglass Bone Graft Particulate

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K000149 ↗

FDA Product Code

LYC

Device Class

Class II

Regulation

21 CFR Part 872.3930

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Perioglass

  Class II

  FDA 510(k) K930115 Active Cleared 4 Nov 1993

• Perioglas Bioglass Bone Graft Particulate

  Class II

  FDA 510(k) K992416 Active Cleared 15 Oct 1999

• Butler Gum Prophy Paste with Novamin

  Class I

  FDA 510(k) K024343 Active Cleared 11 Jul 2003

• Perioglas - Bioglass Bone Graft Particulate

  Class II

  FDA 510(k) K962494 Active Cleared 20 Sep 1996

• What types of surgical procedures is the Novabone-Bioglass Bone Graft Particulate intended for, and how does it support bone regeneration?

  The Novabone-Bioglass Bone Graft Particulate is specifically designed for dental and orthopedic applications where bone regeneration is required. It consists of bioactive glass particles that integrate with natural bone tissue, promoting healing by facilitating new bone formation. This makes it suitable for procedures like bone grafting in dental implants, sinus lifts, or orthopedic surgeries where bone defects need to be filled or repaired.

• Is the Novabone-Bioglass Bone Graft Particulate sterile and single-use, and how should it be handled to maintain sterility?

  Yes, the Novabone-Bioglass Bone Graft Particulate is supplied as a sterile, single-use product, ensuring it is safe for surgical settings without risk of contamination. To maintain sterility, it should be handled using aseptic techniques, opened only in a sterile field, and used immediately after opening. Avoid exposing the particulate to airborne contaminants or reusing it, as this could compromise its sterility and effectiveness.

• What sizes or models of the Novabone-Bioglass Bone Graft Particulate are available, and how is it packaged for use?

  The provided data does not specify exact granular sizes or distinct model numbers for the Novabone-Bioglass Bone Graft Particulate, but it is supplied as a particulate form for surgical use. It is likely packaged in sterile, pre-measured containers or vials to ensure precise dosing during procedures. For exact sizing or packaging details, refer to the manufacturer’s product documentation or contact Usbiomaterials Corp.

• How should the Novabone-Bioglass Bone Graft Particulate be stored, and what are the key considerations for shelf life?

  While the data does not specify exact storage conditions, synthetic bone graft particulates like this typically require storage in a clean, dry environment protected from moisture and extreme temperatures. It should be kept in its original, sealed packaging until use. For precise storage instructions and shelf life, consult the manufacturer’s labeling or instructions for use, as improper storage could affect its efficacy or sterility.

• What regulatory pathway was followed for the FDA clearance of the Novabone-Bioglass Bone Graft Particulate, and how does this affect its use?

  The Novabone-Bioglass Bone Graft Particulate received FDA 510(k) clearance (K000149) under a Special review pathway, determined to be substantially equivalent to a predicate device. This clearance was granted by the FDA’s Dental (DE) Advisory Committee, confirming its compliance with safety and effectiveness standards for bone grafting materials. Clinicians and buyers can rely on this clearance to ensure the product meets regulatory requirements for use in dental and orthopedic procedures.