Dentistry - Denture adhesives
1Key Takeaways
This document classifies dental adhesives used by wearers of removable dentures; and specifies requirements for use, test methods, and information to be provided to users of such products. This document applies to dental adhesives used by consumers and does not include dental lining materials prescribed or applied by d…
2Expert Interpretation
Comprehensive analysis of ISO 10873:2021 on the classification standards, biocompatibility requirements, adhesion strength test methods and packaging labeling specifications of denture adhesives, covering the technical requirements and clinical application guidance of powder/paste/liner adhesives.
Interpretation of the core content of the standard
As an international authoritative standard in the field of denture adhesives, ISO 10873:2021 systematically regulates product classification, physical and chemical properties, test methods, etc. The 2021 version mainly revised key technical parameters such as the measurement method of the pH meter and the surface roughness of the sample holder.
Product Classification System
| Type | Subclass | Morphological Characteristics | Key Indicators |
|---|---|---|---|
| Type 1 (Gel Type) | Class 1 | Powder | Water washability, 1:4 powder-water ratio |
| Class 2 | Paste | pH Diffusion Capacity | |
| Class 3 | Flake/Tape | Minimum size 21mm×21mm | |
| Type 2 (Pad type) - Non-aqueous base 15mm elongation |
Key technical requirements
Biocompatibility
The standard emphasizes the need to pay special attention to the impact of metal ion release on biocompatibility, and recommends referring to ISO 7405 and ISO 10993-1 for evaluation.
Physical and chemical properties
- pH range: 4-10 (measured in a 37℃ water bath)
- Adhesion strength: ≥5kPa (Type 1 needs to pass 7.5/7.6 test, Type 2 needs to pass 7.7 test)
- Stability: needs to pass 3 months accelerated aging at (40±2)℃, (75±5)%RH
Test method innovation
Key equipment for adhesion strength test
The standard specifies the technical parameters of the adhesion tester in detail:
- Load capacity: 10N
- Crosshead speed: 5mm/min
- Sample holder I: diameter (22±1) mm, surface roughness ≤2.0μm
Type 2 products need to use PMMA plate (50mm×50mm) for ductility testing, and the average diameter must be ≥15mm.
Implementation recommendations
Manufacturers
- Establish a powder/water ratio control system (1:4 mass ratio)
- Improve the accelerated aging test procedure (40℃/75%RH)
- Use PMMA material that complies with ISO 7823-2 to make test molds
Clinical institutions
- Pay attention to the difference between the immediate adhesion effect (1 minute test) and durability (10 minutes test) of Type 1 products
- Type 2 products need to be immersed in a 24-hour test before use to evaluate the peeling performance