What is ANSI/ADA Standard No. 135 about?
This standard classifies denture adhesives used by wearers of removable dentures. It also specifies requirements, test methods and instructions to be supplied for the use of such products.
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Standard No. 135
What are the requirements I should know about for denture adhesives?
ANSI/ADA Standard No. 135 sets the following requirements to ensure safety of denture adhesives for use by consumer. Denture adhesives are categorized as one of the following types:
Type 1: glue type
- Class 1: powder form;
- Class 2: cream form;
- Class 3: sheet or tape form.
Type 2: liner type
- pH value
Within the range of 4 to 10 - Microbiology
Testing for microbiological contamination shall be carried out - Stability
No signs of deterioration - Washability (Type 1)
No residual lump - Strength of adhesion to prosthesis (Type 1)
Not less than 5 kPa - Adhesion strength (Type 2)
Not less than 5 kPa - Peeling property (Type 2)
No residual lump - Consistency (Type 2)
Not less than 15mm
What’s the bottom line?
ANSI/ADA Standard No. 135 sets the requirements for properties of denture adhesives that ensure safety for consumer use.