“SmileAlign” is a series of transparent orthodontic plastic bracket made by dentist prescription and customized forming technology. The device is composed of thermoplastic copolyester, and the internal contour is consistent with the shape of all or part of the user's dental crown, which can slowly move the patient's teeth to achieve dentition correction. 3Shape Ortho System： 3Shape Ortho System is a professional computer application for dentists and gingival orthopaedic surgeons to view, monitor, edit, adjust and approve patient‘s various steps to correct the treatment plan. Including the patient’s pre-treatment occlusion image, the expected state of tooth movement and the expected tooth position after the correction is completed. 3Shape Ortho System is used to help doctors approve or change treatment plans. The dentist should thoroughly review the treatment plan at each stage and authorize the company to manufacture orthodontic plastic bracket.
TFDA No. 008685
TFDA No. 008689
TFDA QMS No. QMS1512
USFDA No. K191774
USFDA No. K212803
3D GLOBAL BIOTECH INC. No.2
The “SmileAlign” Orthodontic Aligner System is an oral healthcare product developed using medical-grade materials certified in Taiwan and the United States, ensuring safety and biocompatibility. The system integrates AI-assisted digital design technology to improve aligner precision, reduce human error, and provide a comfortable and aesthetic orthodontic experience. As a contact-type medical device, all products undergo multi-stage ultrasonic cleaning prior to delivery. SmileAlign has passed ISO 10993 biocompatibility testing, and its manufacturing process complies with Medical Device Quality Management System requirements (QMS1512) and Taiwan Medical Device Manufacturing Licenses (No. 008685 / No. 008689). From product design, manufacturing, packaging, labeling, to final release, SmileAlign follows strict PDCA quality management principles. Comprehensive design verification, validation, supplier management, and raw material inspections are implemented to ensure product safety, quality consistency, and compliance with international medical device standards. All products undergo 100% final inspection before release, with complete documentation and R&D oversight maintained throughout the entire process.
“SmileAlign” maintains strict quality control throughout its design and manufacturing processes. Based on clinical feedback data collected over the past two years, the average deviation between planned and final orthodontic outcomes was 0.0538 mm for the upper jaw and 0.0143 mm for the lower jaw, both significantly below the industry standard tolerance of 0.25 mm, demonstrating high treatment accuracy and effectiveness. As a customized medical device product, SmileAlign evaluates quality using four key indicators: dental model printing success rate, aligner manufacturing success rate, design precision, and orthodontic correction accuracy. The recorded results showed a 100% dental model printing success rate, 99% aligner manufacturing success rate, and 99% design precision within ±0.1 mm tolerance. Orthodontic correction accuracy was evaluated based on the occlusal plane, with all deviation values falling within the 95% confidence interval and below the company’s internal acceptable tolerance standard of ±0.0509 mm. These results demonstrate stable production capability, high manufacturing consistency, and reliable product quality.
3D Global Biotech has established its risk management system in accordance with ISO 14971:2019 and CNS 14989, the international and Taiwan national standards for medical device risk management. To ensure effective implementation, the company has formed a dedicated risk management team for its clear aligner products, consisting of R&D engineers, manufacturing engineers, laboratory testing personnel, market analysts, and dental technicians, with professional orthodontists serving as consultants. The team is responsible for risk analysis, risk evaluation, risk control, residual risk assessment, risk review, as well as production and post-market activities, ensuring that product risks are effectively monitored and controlled throughout the entire product lifecycle.
3D Global Biotech has established post-market surveillance procedures and an RMA (Return Material Authorization) system for medical devices to ensure product safety and effectiveness after commercialization. The system includes monitoring report collection, adverse event evaluation, defective product return and replacement handling, as well as regular review and reporting procedures. If any safety risks or performance issues are identified during post-market monitoring, appropriate corrective and regulatory actions will be implemented. When necessary, product withdrawal or recall measures may be initiated to protect user safety and prevent further harm.
The R&D strategy of “SmileAlign” focuses on enhancing product differentiation and market competitiveness. Unlike conventional clear aligner products, SmileAlign integrates proprietary sustained-release drug delivery technologies protected by patents (TWI578968B, TWM622773U), enabling orthodontic treatment to be combined with teeth whitening, periodontal care, and cavity prevention according to patient needs. In addition to the SmileAlign aligner system, related product series have also been filed for patent protection to establish a comprehensive aligner-centered product ecosystem and develop an internationally recognized brand with a complete product portfolio. To date, the company has obtained four invention patents and three utility model patents (Appendix 7), including patents in Taiwan (TWI578968B, TWI794846B, TWI365737B, TWM622773U, TWM483007U) and China (CN106388964B, CN215780918U). In addition, six invention patent applications are currently pending in the United States (63/431,324; 63/431,325; 63/431,328; 17/840,846; 17/844,734) and China (CN202110766062.3).
