This standard gives requirements and test methods for materials used within the tooth to seal the root canal system. It also gives the requirements for what information needs to be provided to the consumer (dentist) on the labeling and packaging of the products for informed decision making.
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Standard No. 57
What are the requirements I should know about for endodontic sealing materials?
ANSI/ADA Standard No. 57 sets requirements for solubility, radiopacity, the setting and working times, and other physical characteristics that are critical for success of such materials in vivo.
- Minimum working time: Not less than 90% of the working time stated by the manufacturer
- Setting time: Within 10% of that stated by the manufacturer
- Flow: Not less than 20 mm
- Film thickness: Not more than 50 um
- Dimensional change following setting: Shall not exceed 1%, or 0.1 % in expansion
- Solubility: Shall not exceed 3% by mass
- Radiopacity: Not less than that equivalent to 3 mm of aluminum
What's the bottom line?
ANSI/ADA Standard No. 57 sets the requirements to ensure that endodontic materials successfully and safely seal root canals for the patient.