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General standards information for lab, clinic and supply staff. It is not clinical or individual medical advice.
Short answer
ISO 4049 is the international standard titled “Dentistry — Polymer-based restorative materials.” The current edition is ISO 4049:2019 (Edition 5, published 2019-05-23), last reviewed and confirmed in 2024. It sets requirements for polymer-based materials used to restore teeth directly or indirectly and for luting, and it replaced ISO 4049:2009, which is withdrawn.
Definition and scope
According to the ISO committee page for the standard (ISO/TC 106/SC 1, “Filling and restorative materials”), the document specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation. They are intended for use primarily for the direct or indirect restoration of the teeth and for luting.
The luting materials in scope are those intended for the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. The standard sits under ICS code 11.060.10 (dental materials).
What ISO 4049 does not cover
Much of the confusion around this standard is about neighbouring documents. The ISO scope statement names three exclusions and the standards that apply to them instead.
| Material | In ISO 4049:2019? | Where the ISO scope points |
|---|---|---|
| Polymer-based direct or indirect restorative materials | Yes | ISO 4049 |
| Polymer-based luting materials without an adhesive component | Yes | ISO 4049 |
| Polymer-based luting materials with an adhesive component within the structure of the material | No | ISO/TS 16506 |
| Polymer-based materials intended to prevent caries | No | ISO 6874 |
| Core materials, and materials used for veneering metal sub-frames | No | ISO 10477 |
Source: ISO committee page for ISO 4049:2019, checked 2026-10-30.
How the standard is used in practice: the properties it tests
The full text of ISO 4049 is sold by ISO and national standards bodies. The Norwegian Institute of Dental Materials (NIOM) publishes a summary table of the requirements it tests against, with the clause numbers of ISO 4049. The values below are as summarised by NIOM (page checked 2026-10-30); they are not quoted from the standard’s own text, and the standard itself remains the authority.
| Property | Requirement as summarised by NIOM | ISO 4049 clauses cited by NIOM |
|---|---|---|
| Flexural strength (light-cured, polymer-based) | Minimum 80 MPa (Type 1); minimum 100 MPa (Type 1, class 2, Group 3); minimum 50 MPa (Type 2) | 5.2.9 / 7.11 |
| Depth of cure (light-cured) | Minimum 1.5 mm, or not more than 0.5 mm below the manufacturer’s stated value; minimum 1 mm if labelled opaque | 5.2.8 / 7.10 |
| Colour stability (light-cured) | Not more than a slight change in colour on visual inspection after water sorption and irradiation | 5.4 / 7.13 |
| Water sorption and solubility | Sorption at most 40 μg/mm³; solubility at most 7.5 μg/mm³ | 5.2.10 / 7.12 |
| Film thickness (dual-cured or chemical-cured luting) | Not more than 10 μm above the manufacturer’s claimed value, and in any event not greater than 50 μm | 5.2.2 / 7.5 |
| Working time (dual-cured or chemical-cured luting) | At 60 seconds after completion of mixing, the material must form a thin layer with no detectable change in homogeneity | 5.2.4 / 7.7 |
| Setting time (dual-cured or chemical-cured luting) | Not more than 5 minutes (Class 1) or not more than 10 minutes (Class 3) | 5.2.5, 5.2.6 / 7.8 |
The class, type and group designations come from the standard itself, which defines them.
Types and related concepts
The standard covers two broad delivery routes named in its scope: materials that are mixed (mechanically or by hand) and materials activated by external energy, intra-orally or extra-orally. Materials that fall outside it are handled by ISO/TS 16506 (adhesive-containing luting materials), ISO 6874 (caries-preventive polymer materials) and ISO 10477 (core and veneering materials). For the wider research and clinical context of the field, see dental and oral health research.
Where it matters for labs, clinics and supply decisions
- Edition. The ISO page lists ISO 4049:2019 as Edition 5, confirmed in 2024, and lists ISO 4049:2009 as withdrawn. A product document that cites the 2009 edition therefore cites a withdrawn text.
- Scope. A conformity statement to ISO 4049 relates only to the materials in the table above. An adhesive luting material, a caries-preventive material or a core material is assigned by the ISO scope to a different document.
- Test parameters. Several limits are relative to the manufacturer’s own stated values (depth of cure, film thickness), so the stated value on the product documentation is part of what is being tested against.
- Related CASRAI pages. For adjacent device-standards and safety-reporting background see Medical Device Reporting (MDR), ISO 14155 (clinical investigation of medical devices, a separate standard) and the dental office medical emergency supply checklist.
Common misunderstandings
- “ISO 4049 covers all dental filling materials.” It does not. Its scope is polymer-based materials, and the ISO scope text excludes caries-preventive materials (ISO 6874), core and veneering materials (ISO 10477) and adhesive luting materials (ISO/TS 16506).
- “The 2009 edition is still the standard.” The ISO page shows the 2009 edition as withdrawn and the 2019 edition as current.
- “A standard sets one pass mark for every material.” The NIOM summary shows different minimums by type (for example flexural strength of 80, 100 or 50 MPa) and different time limits by class.
Frequently asked questions
What is ISO 4049?
It is the ISO standard “Dentistry — Polymer-based restorative materials,” specifying requirements for dental polymer-based materials for restoring teeth and for luting (ISO committee page, checked 2026-10-30).
Which edition of ISO 4049 is current?
ISO 4049:2019, Edition 5, published 2019-05-23 and confirmed in 2024. It replaces ISO 4049:2009, which is withdrawn.
Does ISO 4049 cover caries-preventive materials?
No. The ISO scope excludes polymer-based materials intended to prevent caries and refers to ISO 6874.
Does ISO 4049 cover adhesive luting materials?
No. Luting materials with an adhesive component within the structure of the material are referred to ISO/TS 16506.
Which properties does ISO 4049 test?
As summarised by NIOM: flexural strength, depth of cure, colour stability, water sorption and solubility, and for luting materials film thickness, working time and setting time.
Sources
All sources checked on 2026-10-30.
- ISO, “ISO 4049:2019 Dentistry — Polymer-based restorative materials” (committee page): https://committee.iso.org/standard/67596.html, checked 2026-10-30.
- Swedish Institute for Standards (SIS), national adoption listing for the 2019 edition: https://www.sis.se/en/produkter/health-care-technology/dentistry/dental-materials/ss-en-iso-40492019/, checked 2026-10-30. Confirms the same scope wording, including the luting examples (inlays, onlays, veneers, crowns, bridges).
- Norwegian Institute of Dental Materials (NIOM), summary of tested requirements: https://www.niom.no/testing–standardisation/niom-tested, checked 2026-10-30. A secondary summary, used only for the property table above.
