Overview
EN ISO 10477:2020 (ISO 10477:2020) is a CEN-adopted international standard for polymer-based crown and veneering materials used in dentistry. It classifies polymer dental restorative materials for laboratory-fabricated permanent crowns and veneers and specifies the requirements and test methods manufacturers and test laboratories must use to demonstrate conformity. The standard also covers polymer-based materials that rely on chemical adhesion to a substructure without macro-mechanical retention (for example, without beads or wires).
Key topics and technical requirements
The standard defines both material classification and detailed performance requirements. Major technical topics include:
- Classification of polymer-based crown and veneering materials by type and class.
- Depth of cure - procedures and apparatus for assessing adequate polymerization of light-cured materials.
- Surface finish - criteria and test methods for surface quality after finishing and polishing.
- Flexural strength - specimen preparation, test apparatus and expression of results for mechanical durability.
- Bond strength - including requirements for special bonding systems that do not use macromechanical retention (note: the standard addresses values such as higher than 5 MPa where applicable).
- Water sorption and solubility - procedures to assess dimensional stability and material degradation in aqueous environments.
- Shade consistency and colour stability - methods for visual inspection and instrumental colour comparison over time.
- Biocompatibility - ensuring materials meet necessary biological safety expectations.
- Sampling, packaging, labelling and instructions for use - guidance for conformity testing, clinical handling and regulatory traceability.
The document provides step-by-step measurement and test methods (apparatus, specimen preparation, procedures and result expression) for each requirement.
Applications and who uses this standard
EN ISO 10477:2020 is essential for:
- Dental materials manufacturers - to design, test and document polymer crown/veneer products for regulatory compliance and market access.
- Dental laboratories and technicians - to select certified materials and understand performance expectations for laboratory-fabricated restorations.
- Testing and certification bodies - to perform standardized laboratory tests for conformity assessment.
- Regulatory authorities and procurement teams - to specify compliant products in purchasing and regulatory frameworks.
- Clinicians and dental practice managers - to make informed choices about materials based on documented properties like bond strength, durability and shade stability.
Related standards
- Supersedes EN ISO 10477:2018 (now replaced by the 2020 edition).
- Prepared by ISO/TC 106 “Dentistry” in collaboration with CEN/TC 55; integrates with national standards adopted across CEN member countries.
Keywords: EN ISO 10477:2020, ISO 10477:2020, polymer-based crown and veneering materials, dental materials standard, dentistry test methods, dental crowns, dental veneers, bond strength, colour stability.
