The journey from raw titanium rod to becoming a medical device known as a dental implant has more than 45 different stages. In this video, we will focus on the key moments, based on the manufacturing process at DSI Dental Solutions factory in Ashdod, Israel.
Production begins with rigorous quality control of incoming raw material. No materials will be allowed for production until they pass a predefined program of tests and analysis.
1. The first production stage is to machine the implant geometry from the bars of raw material. Manufacturing tolerances are just a few microns to guarantee a precision effect when using implants with DSI original abutments. Preparation of CNC machines is a complex process of software setup and fine tool adjustment. Machines are set by specially trained operators - no production batch can start until a quality check is performed. Each setup might take up to 12 hours for one production lot.
2. During the machining process, operators and inspectors are constantly measuring parts and evaluating surface finishings in order to keep them in precise control. In-process measurement protocols are defined to ensure the parts remain within their tolerance throughout the entire production. While conventional CNC Citizen machines are used, DSI has developed unique and innovative machining tools to speed up and improve those processes.
3. After machining and initial wash and polish, parts are passed further for the cleaning stage. Cleaning and degreasing are a critical part of medical device production. The process, which includes several stages of washing, agitation and rinsing, is validated using the "worst-case scenario" method to ensure that cleaning can consistently meet its specifications under all circumstances. Ultra-pure, high-quality demineralized water is used to feed the machines.
4. Once the implant blank is ready and checked, the surface treatment process begins. Some parts are anodized priorly, while the main stage is sandblasting, which creates a macrostructure on the implant's surface. While fully automated, the process is rigorously validated and verified for optimal surface roughness and grain size.
5. Then we come to the second stage of surface treatment, using acids which produce a microporosity on the implant surface. Such microstructure is more receptive to the osteoblast activity and also free of residue particles that can slow down osseointegration.
6. After the acid treatment, implants are passed to the clean room inside the antibacterial media without being exposed to the environment. The implants are left to dry and then checked again under the microscope installed in the clean room before being connected to the carrier and placed inside the sterile vial. The clean room operators has been specifically trained and supervised, while the clean rooms are subject to a comprehensive program of particle and microbiological sampling to ensure they continue to meet the specifications required for the DSI implants.
7. The last stage is labelling (to ensure full traceability), sending to gamma-ray sterilization and final packaging.
In summary, this presentation provides insight into the meticulous and quality-focused dental implant manufacturing process at DSI Dental Solutions. With a strong emphasis on precision, hygiene, and innovation, each implant undergoes a thorough journey to meet stringent medical device standards. From raw materials to sterile packaging, DSI's process reflects a commitment to excellence in dental implant production.
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