DSI Synthetic Calcium Phosphate Surgical Material Instruction Manual
- June 16, 2024
- DSI
Table of Contents
DSI Synthetic Calcium Phosphate Surgical Material
Product Information
The DSI Syntoss is a synthetic calcium phosphate surgical material designed for the restoration of hard tissue defects. It is manufactured by DSI Ltd. and is intended for use in general dental and maxillofacial surgery, traumatology, and orthopedics. The material is made from a combination of tricalcium phosphate (60%) and hydroxyapatite (40%), and is created through a sintering process of synthetic materials. It does not contain any substances of animal origin and is biologically compatible with body tissues. The granules have a high micro-, macro-, and intergranular porosity, which provides optimal conditions for fast bone recovery. The material is also radiopaque, allowing for easy visibility during procedures.
Specifications:
- Material Type: Synthetic calcium phosphate
- Composition: Tricalcium phosphate (60%), Hydroxyapatite (40%)
- Porosity: High micro-, macro-, and intergranular porosity
- Absorption Rate: Completely absorbed in 6 to 9 months
- Available Sizes: Granules (500-1000μm), Blocks (4 pcs in vial), Cones (2 pcs in vial)
- Manufacturer: DSI Ltd.
- Manufacturer Address: 59 haAvoda str. Ashdod, 7706300 Israel
- Contact Number: +972-8931-7235
- Website: www.dsisrael.com
Product Usage Instructions
Before using DSI Syntoss, it is important to perform the necessary preparatory surgical procedures. The granules can then be mixed with the patient’s blood or saline solution in a sterile dappen dish. For large bone defects, it is recommended to mix the granules with autologous bone particles from the same patient for the best results. The mixture can be applied to the operative site using a dental spatula. After applying the material, the operative site should be closed by joining together the wound edges with suture stitches. It is crucial to ensure proper closure for optimal healing.
Storage and Handling
It is essential to handle and store the DSI Syntoss material properly to maintain its quality and effectiveness. The following guidelines should be followed:
- Do not use the product if the packaging shows any signs of damage, previous opening, or moisture.
- Store the product according to the manufacturer’s instructions to avoid changes in its working characteristics and to maintain its shelf life.
- Transport and store the product in compliance with the manufacturer’s guidelines.
The manufacturer is not responsible for any loss of quality caused by failure to comply with the specified transportation, storage, and usage conditions. The user assumes responsibility for using the material for purposes other than those specified by the manufacturer.
Frequently Asked Questions
Q: What is the composition of DSI Syntoss?
A: DSI Syntoss is composed of 60% tricalcium phosphate and 40% hydroxyapatite.
Q: How long does it take for DSI Syntoss to be completely absorbed?
A: DSI Syntoss is completely absorbed in 6 to 9 months, depending on the size of the granules and tissue regeneration potential.
Q: Can DSI Syntoss be mixed with autologous bone?
A: Yes, for large bone defects, it is recommended to mix DSI Syntoss with bone particles from the same patient (autologous bone) for the best results.
Q: How should I store DSI Syntoss?
A: Follow the manufacturer’s instructions for storage to maintain the working characteristics and shelf life of the material.
Synthetic calcium phosphate surgical material for restoration of hard tissues defects
DSI Syntoss
INSTRUCTIONS FOR USE
DSI Syntoss bone material supplien in the form of granules based on β-tricalcium phosphate (60%) with hydroxyapatite (40%).
PURPOSE
DSI Syntoss is osteoplastic material, for optimisation of bone regeneration in
general dental
and maxillofacial surgery, as well as in traumatology and orthopedics.
Prepared by sintering of synthetic materials, it does not contain substances
of animal origin, biologically compatible with body tissues. Granules have a
high micro-, macro- and intergranular porosity, creating ideal conditions for
the fast recovery of the bone. The material is radiopaque.
FIELD OF USE
- Parodontics: filling a two-or multi-bone pockets and bi-and tri-furcations of the teeth, augmentation of the atrophied sinus.
- Implantology: sinus lifting or sub-antral augmentation (mixed with patient bone or allograft), filling of alveolar defects for supporting of sinus base after the tooth extraction, filling extraction defects prior the implant placement.
- Cyst defects: Defects after extirpation of the bone cyst, defects after resection of the root apex and defects after removal of impacted teeth surgically, as well as other multi-grid bone defects of the alveolar processes and facial bones.
FEATURES
Sterile and gradually resorbable bone substitute material.
Releases calcium and phosphate ions to help promote new bone formation.
Syntoss arrives in the different particle size as following:
- 100-500 µm – small periodontal bone defects;
- 500-1000 µm – universal particle size for most cyst and alveolar defects;
- 1000-2000 µm – recommended for large defects and sinus lifting.
The choice of granules size depends on the size and the location of the defect.
DSI Syntoss granules have an osteoconductive micro-and-macroporous structure that fosters dense new bone growth. Depending on the size of the granules and tissue regeneration potential of the materials, DSI Syntoss is completely absorbed in 6 to 9 months. Granules dissolving process takes place in parallel with the regeneration.
DIRECTION FOR USE
After the necessary preparatory surgical procedures, the granules can be mixed
with the patient’s blood or with saline solution in a sterile. Dappen dish
before being placed onto the operative site using a dental spatula. For large
bone defects, mix with bone particles from the same patient
(autologous bone) for the best results. The operative site will have to be
closed by joining together the wound edges (coaptation) with suture stitches.
PACKAGING
Sterile vial in blister package (sterilised by gamma radiation – minimal dose: 25 kGy).
STORAGE
Store in a dry and dark place in tightly closed containers at temperature
(+5°C…+25°C). Avoid contact with moisture! Do not use after the expiry date
mentioned on the outer package.
ATTENTION! The sterility of the product cannot be guaranteed if the package bears evidence of damage, has been opened previously or wet.
Failure to comply with the conditions of storage leads to a change of the
working characteristics of the material and decrease the shelf life of the
material.
The manufacturer is not responsible for any loss of quality caused by the
failure to comply with terms of transportation, storage and use established by
the manufacturer for this product. Responsibility for the use of the material
for purposes other than those specified by the manufacturer falls on the user.