Odne® Clean
The Clinical Challenge
Root canal procedures present a growing challenge: narrow canals, sharp curvatures, and high
patient sensitivity demand precise, controlled interventions.
Traditional cleaning methods often:
– Limit access to complex anatomies
– Increase treatment time and clinician fatigue
– Interrupt workflow
– Cause discomfort for patients
There was a clear need for an endodontic cleaning system that was both gentle and highly
effective.
The Idea Behind
the Innovation
Odne ® Clean was developed as a compact, ergonomic, table-top endodontic cleaning system. Its fluid-activation technology allows safe and precise root canal treatment in fewer steps.
Key benefits include:
– Compact, ergonomic design for ease of handling
– Thinnest single-use tip on the market for better access
– Detachable waste container and replaceable saline bag for workflow efficiency
– Faster, smoother, and more comfortable procedures
Clinical evaluations confirmed significant improvements in procedure time, handling, and patient comfort.
Odne® in action
The system combines intuitive controls, a lightweight handpiece, and the most flexible tip for accessing every canal curvature.
Highlights:
– Single-handed activation
– Streamlined workflow for clinicians
– Reduced risk of procedural errors
– Enhanced patient comfort
The result is a precise, efficient, and gentle treatment experience, improving outcomes for both clinicians and patients.
“Collaborating with Creanova has been a rewarding experience thanks to their tailored development and manufacturing services that perfectly align with our needs. Their team consistently demonstrates high motivation, dedication, and a pragmatic approach to problem-solving. It’s been a true pleasure partnering with Creanova on our mission to transform endodontics.”
Dr. Mark Bispinghoff
COO & Co-founder
Design &
Development &
Contract Manufacturing
The development of Odne® followed a structured, multidisciplinary approach, integrating clinical insight, ergonomic refinement, engineering precision, and manufacturability analysis.
From Proof of Concept to market-ready device, Creanova oversaw the entire process—engineering, industrialization, manufacturing, and in-house assembly—ensuring all decisions met functional requirements and quality standards.
Odne® represents the first hydro-dynamic cavitation-based device for root canal debridement, using sterile water as the primary irrigation medium (Class II). Its development enabled entry into the FDA-regulated US market.
This excellence in medical device design and engineering was internationally recognized with the Good Design Award 2025, awarded to OdneClean – Cavitation-based Root Canal Debridement Device. | 2025 – Good Design Awards
confirming the project’s innovation, usability, and technical quality.
The result is a reliable, high-performance solution that combines usability, mechanical consistency, and production efficiency, while ensuring cost-effective scalability for serial manufacturing.
Layout Analysis
From the initial layout analysis to the final product design, every decision was informed by the optimal arrangement of internal components—fluid paths, pumps, valves, and sensors—while ensuring isolation from the PCB zone and achieving a compact, table-top form factor.
Technical research extended beyond the dental sector, exploring solutions in other industries, such as consumer appliances, to overcome specific engineering challenges.
Product Design
Concurrently, product design incorporated in-depth market research in dental irrigation and consumer trends, shaping the handpiece and main unit.
The concept designed were developed, exploring different visual and functional approaches with the membrane keyboard, while respecting the constraints defined during the layout phase.
The final aesthetics applied client brand colors and refined the interface keyboard design for usability and visual consistency.
Proof of Concept (PoC)
To ensure a set of prototypes that were functional, reliable, and ready for the transition into final product engineering.
– Optimal layout of fluid paths, pump, valves, and sensors
– PCB isolation for IP22 protection and mechanical safety, preventing external access
– Compact table-top structure validated through iterations
– Cross-industry technical benchmarking for high-performance fluid management
– Iterative refinement focused on usability and clinical workflow
Product Engineering & Performance
Creanova fully engineered Odne® for mass production, refining both table-top and handpiece components.
– Material and component selection ensuring durability
– PCB integration with protective enclosures
– Optimized assembly process for efficiency
– Compliance with medical device and safety standards
– IP-rated protection: table-top (IP22), handpiece (IP44)
– Mechanical validation through drop and impact tests compliant with IEC 60601
Optimization for Scalable Production
– Updated 2D drawings with optimized tolerances
– Material and geometry refinements to improve stability and reduce manual adjustments
– Defined torque values for consistent assembly
– Process tuning to minimize cosmetic defects such as scratches, halo marks, and welding lines
Together, these interventions ensured a robust, high-performance device, ready for reliable large-scale manufacturing.
DFM & Production Refinement
Using parametric CAD and iterative tooling adjustments, the team optimized:
– Injection-moulding behavior and material flow
– Rib geometry, draft angles, tolerances and split lines
– Cooling strategies to stabilize shape and reduce warpage
– Assembly paths and defined torque values
These actions improved snap-fit safety, interface stability, and LED diffusion, enabling a smooth transition to industrial production.
Material Selection & Compliance
Component materials were chosen to meet functional, aesthetic, and regulatory requirements:
– Mechanical strength and dimensional stability
– Chemical resistance and sterilization compatibility
– Biocompatibility and regulatory compliance (ISO 10993, EMC)
– Surface finish, color uniformity (VDI, RAL references)
– LED light diffusion for button visibility
This ensured device reliability and regulatory compliance.
EMI/EMC Shielding
To ensure PCB signal integrity, custom 3D-printed protective enclosures were developed as extra shells inside the product.
– 3D-printed shells created with Multi Jet Fusion using HP PA11 material
– Extra EMI/EMC walls shield the PCB from external and internal electromagnetic interference
– Protects signal transmission and prevents information loss
– Compact design integrates seamlessly within the final product assembly
Quality Control & Parts Validation
Ensuring every part meets strict standards is essential for reliable device performance.
– Dimensional and visual inspection of injection-molded parts according to agreed quality standards
– Color measurement using spectrophotometer for consistency
– 3D scanning for dimensional control and Master Sample identification
– Assembly testing to verify proper fit and function
Mold & Part validation
– Mold validation through dimensional and assembly quality checks (QC-dim, QC-asm)
– Startup management and first production support
– Labeling design compliant with UDI (Unique Device Identification) requirements
– Traceability and registration aligned with MDR (EU 2017/745)
Contract Manufacturing
Complete assembly is carried out under ISO 13485 standards, ensuring high quality and compliance.
– Inline and final testing of all assembled units
– Batch release documentation to verify all controls and issue Certificate of Conformity (COC)
Clinical Impact
Odne® provides tangible advantages in clinical and operational workflows:
– More reliable mechanical behavior during use
– Stable lid handling, with controlled snap-fit opening
– Better light visibility thanks to improved LED diffusion
– Higher overall durability during accidental impacts
– More consistent assembly, reducing maintenance and QC time
These refinements contribute to a smoother user experience and improved device reliability.