GranuMas® is a Class III product certified with CE Mark (CE 586440) by BSI, NETHERLAND. It is composed of Hydroxyapatite (HA), a synthetically made bone graft of calcium phosphate material, which is like a natural human bone mineral. Having composition and properties identical to human bone minerals, GranuMas® is an innovative alternative material for surgeries requiring bone grafting procedures for non-load bearing applications in Orthopedics, ENT, Dental, and Maxillofacial.
The fabrication of GranuMas® conforms to all the required criteria for surgical implants based on ISO 13779-3:2018/Amd.1:2021(E) Standards: “Implants for surgery – Hydroxyapatite – Chemical analysis and characterization of crystallinity ratio and phase purity” and ISO 13485:2016 Standards: “Medical Devices – Quality Management Systems“.
His technology-driven project was the outcome of joint research efforts between SIRIM, Malaysian Institute of Nuclear Technology (MINT), Universiti Sains Malaysia (USM), Universiti Kebangsaan Malaysia (UKM), and the International Islamic University of Malaysia (IIUM).
What is GranuMas®?
GranuMas® is a Synthetic Calcium Phosphate (non-animal) bioceramic-based bone graft material chemically known as Hydroxyapatite. It is 99% identical to human bone minerals. Thus, GranuMas® is the innovative alternative in surgical applications requiring bone grafting procedures for non-load bearing in Orthopaedics, ENT, Dental, and Maxillofacial.
Hydroxyapatite is well known for its properties of “bioactive” and “osteoconductive” – i.e enhance bone growth and bone bridging, as it acts as a scaffold in any bone void/loss for bone healing.
It is an excellent alternative material for bone graft after patient-own bone (autograft) since it will reduce the amount of autograft needed for harvesting (i.e GranuMas® can be used as a bone graft expander when mixed with autograft to increase the bone graft volume).
The option of using GranuMas® alone for treatment will also reduce the need for 2nd site surgery for harvesting the patient’s own bone. Moreover, this will reduce the cost of double surgeries, trauma, morbidity, hospital stay, and risk of infection for the patient.
GranuMas® is also an excellent bone graft candidate for patients with low bone regenerative properties (e.g., diabetics, osteoporosis, hypertension, geriatric patients). It provides bone volume and strength due to its low resorption rate – especially for osteoporotic patients.
Manufacturer and Certification
GranuMas® is manufactured under GMP ISO 13485:2016 and is European CE Mark certified by BSI Netherlands. GranuMas® also has HALAL Certified by JAKIM Malaysia.
Pre-Clinical Testings (ISO 10993) Clinical Trials (ISO 14155)
SKU for GranuMas:
|PRODUCT TYPE||SIZE||DIMENSIONS||0.5 cc||1.0 cc||2.0 cc||5.00 cc|
|GranuMas® Spherical||S||0.2 – 0.5 mm|
|GranuMas® Spherical||M||0.5 – 1.0 mm|
|GranuMas® Spherical||SM||0.2 – 1.0 mm|
|GranuMas® Spherical||L||1.0 – 2.5 mm|
|GranuMas® Spherical||XL||2.5 – 5.0 mm|
|GranuMas® Cube||~5 mm x 5mm x 5mm|
|GranuMas® Pin||~3 mm x 3mm x 3mm|
|GranuMas® Chip||~1.0 – 2.5mm|
TREATMENT CONCEPT FOR TOOTH EXTRACTION
Dental Treatment solution that meets the unique needs while providing patients with a beautiful smile that lasts for decades
What happens after tooth removal?
- The bone recedes in the weeks and months after tooth removal. This might cause some of the following problems:
- The gum follows the receding bone leading to uneven teeth structure.
- If you wear a bridge, the resulting gaps make it more difficult or impossible to clean.
Difficulty with articulation:
- The change in the mouth affects articulation which leads to expensive and complicated follow-up treatments:
The loss of bone has to be compensated later with laborious bone and soft-tissue augmentation.
Benefits of Treatment using Synthetic Bone Graft
Your bone remains stable
- You will have time flexibility for the subsequent treatments
The gum condition is maintained
- Your smile stays attractive
Further treatment is easier
- You save time and money in the long term
Timely preventive measure
- You may avoid complicated procedures in the future