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Dental Device Risk Classification Chart
Device Category Name
(FDA Product Code Name)
Measurer, gingival fluid
Tester, pulp
Gel, electrode, for pulp tester
Device, caries detection
Laser, fluorescence
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How to fill out dental device risk classification
How to fill out dental device risk classification
01
Determine the intended use of the dental device.
02
Identify the potential risks associated with the device.
03
Classify the risks according to regulatory guidelines.
04
Assign appropriate risk levels to each identified risk.
05
Prepare documentation detailing the risk classification process.
06
Review and validate the risk classification with relevant stakeholders.
07
Submit the risk classification documentation to the appropriate regulatory body.
Who needs dental device risk classification?
01
Manufacturers of dental devices
02
Regulatory authorities
03
Healthcare professionals
04
Dentists and dental clinics
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What is dental device risk classification?
Dental device risk classification is a system used to determine the level of risk associated with a particular dental device.
Who is required to file dental device risk classification?
Manufacturers of dental devices are required to file dental device risk classification.
How to fill out dental device risk classification?
Dental device risk classification can be filled out by providing information on the device, its intended use, and any associated risks.
What is the purpose of dental device risk classification?
The purpose of dental device risk classification is to ensure that appropriate regulatory controls are applied to devices based on their level of risk.
What information must be reported on dental device risk classification?
Information such as device description, intended use, risk analysis, and regulatory history must be reported on dental device risk classification.
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