ISO 10477:2020

Overview

ISO 10477:2020 - Dentistry - Polymer-based crown and veneering materials is the international standard that classifies polymer-based materials used for laboratory-fabricated permanent veneers and crowns and defines the requirements and test methods to demonstrate conformity. Published as the fourth edition in 2020, the standard also covers polymer-based crown and veneering materials that claim adhesion to a substructure without macro-mechanical retention (for example, without beads or wires).

Key topics and technical requirements

The standard sets out both classification and detailed test methods to evaluate performance and safety. Major technical topics include:

• Classification of polymer-based crown and veneering materials for dental use.
• Requirements and corresponding test methods for critical material properties:
  • Depth of cure (polymerization effectiveness)
  • Surface finish (polishability and texture)
  • Flexural strength (mechanical resistance under bending)
  • Bond strength, including special bonding systems where adhesion is claimed without macro-mechanical retention
  • Water sorption and solubility (dimensional stability and leaching)
  • Shade consistency and colour stability (aesthetic consistency across batches and after aging)
  • Biocompatibility guidance (references provided for biological assessment)
• Sampling rules for tests, and detailed measurement and test procedures (apparatus, specimen preparation, procedures, expression of results).
• Packaging, labelling and instructions for use requirements to support safe, effective clinical application.

ISO 10477 also contains normative references used in testing and classification (e.g., ISO 1942, ISO 3696).

Practical applications and users

This standard is intended for practical use by:

• Dental materials manufacturers - to develop, test and document polymer-based crown/veneer products and demonstrate conformity.
• Dental laboratories - to understand material performance characteristics and accept materials for laboratory fabrication.
• Test laboratories and quality assurance teams - to apply standardized test methods for product certification and quality control.
• Regulatory bodies and procurement professionals - to evaluate product specifications and compliance evidence.
• Clinicians and prosthodontists - to interpret manufacturer claims (e.g., bonding without mechanical retention) and select appropriate restorative materials.

Adopting ISO 10477 helps ensure consistent performance, predictable aesthetics, and regulatory readiness for polymer-based dental restorative materials.

Related standards

• ISO 10993-1 and ISO 7405 (recommended for biological hazard assessment and biocompatibility)
• ISO 1942 (dental vocabulary)
• ISO 3696 (water for analytical use)
• ISO 6344-1, ISO 6507-1 (referenced test/measurement methods)

Keywords: ISO 10477:2020, polymer-based crown and veneering materials, dentistry standard, test methods, depth of cure, flexural strength, bond strength, shade consistency, colour stability.