This book presents a comprehensive examination of customized orthodontic brackets produced through additive manufacturing (AM), with a particular focus on metal powder-bed fusion technologies and post-processing strategies. It explores the challenges associated with achieving adequate surface smoothness, corrosion resistance, and long-term biocompatibility in patient-specific orthodontic devices and presents original case study data that provide practical insights into surface topography, oxide film stability, and clinical performance. In addition, the book offers practical guidance on FDA regulatory pathways, including 510(k) considerations, risk management, and process validation, equipping readers with both scientific understanding and actionable knowledge to support device development, optimization, and regulatory approval. This book is intended for materials scientists, manufacturing engineers, orthodontic researchers, and medical device professionals working with additive manufacturing and will also be valuable to regulatory specialists, graduate students, and clinicians interested in customized orthodontic technologies and advanced digital manufacturing workflows.
Features:
- Discusses the aggressive oral environment and corrosion drivers, including fluctuating pH, salivary ions, biofilms, and temperature effects on stainless steel brackets.
- Covers additive manufacturing technologies, including selective laser melting (SLM), direct metal laser sintering (DMLS), and electron beam melting (EBM) for orthodontic applications.
- Explains surface finishing methods critical for clinical viability, including electropolishing, mechanical tumbling, thermal post-processing, and protective coatings.
- Presents experimental investigations employing microscopy, X-ray photoelectron spectroscopy (XPS), and energy-dispersive spectroscopy (EDS) to characterize the surface roughness and composition of AM versus conventional brackets.
- Explores how post-processing techniques such as rotary tumbling and electropolishing affect bracket performance, friction, bacterial adhesion, and clinical reliability.
- Bridges engineering research and regulatory requirements, including risk management, biocompatibility evaluation, and process validation for additively manufactured medical devices.
- Provides the first dedicated book focused on the intersection of orthodontic bracket design, additive manufacturing, surface engineering, and regulatory considerations, representing a unique contribution that addresses a significant gap in the current literature.
Elena Kostenko earned her first M.S. degree in Automated Systems Engineering in 2010, graduating with honors.She later pursued advanced training in medical device development, earning an M.S. in Industrial and Systems Engineering from North Carolina State University, also with honors. Since 2020, she has worked at CDB Corporation as a manufacturing engineer and project manager, supporting medical device design, manufacturing optimization, and regulatory activities. She has led medical device development projects, encompassing management and functional activities for orthodontic treatment-planning software implementation and its FDA 510(k) submission. Her research spans additive manufacturing, biomaterials, and digital orthodontics. She has authored scholarly work on nanotechnology in orthodontics, shape-memory alloys, and nanomedicine-based drug delivery systems. Her current research focuses on surface finishing and corrosion control of additively manufactured orthodontic brackets, with the goal of improving biocompatibility, clinical performance, and patient safety.
