Instructions for use

Octabone® is a biocompatible, porous, inorganic mineral matrix for use in oral and maxillofacial surgery to repair bone defects. It is derived from bovine bone through a special manufacturing process that removes organic material.

 

Octabone® is packaged and sterilized using gamma irradiation. The shelf life is 5 years for Octabone® and 3 years for Octabone® Syringe. Octabone® has a highly cancellous structure similar to human bone demonstrated under high magnification.

Indications 

(Intended use)

  • Alveolar ridge defects

  • Sinus Augmentation.

  • Extraction defects.

  • Periodontal defects with or without products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).

  • Peri-implant defects with or without products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).

Usage

Practitioners should follow surgical principles according to standard medical or dental practice.

  • Remove any soft tissue or granulation tissue carefully and expose fresh bone.

  • Completely soak Octabone® with saline solution or the patient’s blood product before application.

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  1. Octabone®: Fill the defect with prepared Octabone® using a sterilized spatula or surgical spoon.

  2. Octabone® Syringe: After unscrewing the cap, completely soak Octabone® by drawing saline solution or the patient’s blood product into the syringe. Press the plunger and apply Octabone® directly into the defect site.

 

  • Avoid applying excessive pressure on Octabone® particles to maintain its multiporotic nature. Breaking Octabone® down into smaller pieces may adversely affect the surgical site’s healing rate.

  • Apply protective membrane over applied Octabone® as necessary.

  • Do not overfill defects.

  • Do not leave defects open.

  • Surgical dressing may be placed over the wound.

  • 6 months healing time prior to implant placement is recommended, but the operator should evaluate and make his or her own determination.

Contraindications

Octabone® is not recommended for use in patients with the following conditions:

  • Osteomyelitis of or near the bone defect site

  • Blood dyscrasias

  • Heavy tobacco use

  • History of radiation therapy

  • Diabetes

  • Advanced liver or kidney disease

  • Hypo- or hyperthyroidism


Medical consultation prior to use is recommended at the discretion of the practitioner 

Precautions

  • Octabone® should be used by only trained dentists or oral surgeons.

  • Efficacy in pediatric patients is not known.

Storage & Handling

  • Store in dry conditions at 4-30℃.

  • The sterile packaging should be opened only time of use. 

  • Single use only.  Do not re-sterilize the product.

Adverse reactions

Common surgical complications may include inflammation, fever, edema, pain, bleeding, loss of function, decreased bone growth.

Caution

Federal law restricts this device to sale by or on the order of a physician or dentist.

Look. Compare. Decide.

 

Porosity, vitrification, and particle composition

Octabone®

High-quality porosity, non-vitrified rough surface

B bone graft

Porosity damaged

A bone graft

Non-porous, vitrified smooth surface

C bone graft

All cortical particles

D bone graft

Cortical particles included

 

Octabone® Surface

Natural rough topography (SEM view)

Product particle size & weights

Octabone® comes in vials & syringes

0.25g | 0.25cc

0.2-1.0mm

0.50g | 0.50cc

0.2-1.0mm

1.00g | 1.00cc

0.2-1.0mm

2.00g | 2.00cc

0.2-1.0mm

0.25g | 0.25cc

0.2-1.0mm

0.50g | 0.50cc

0.2-1.0mm

 

*All weights coming soon in 1.0-2.0mm particle size

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