TOOTH POWDER TYPE-2 (Fluoridated) IS 5383:2021

Method Ref.: IS 5383:2021 |TAT : 7 Days*
Required sample quantity : 200-250 gm
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Description

Tooth Powder Type-2, as defined under IS 5383:2021, is a fluoridated oral hygiene product formulated for daily dental care. It contains fluoride compounds in controlled concentrations, along with mild abrasives, surfactants, and other permitted excipients that aid in cleaning teeth, preventing dental caries, and maintaining oral freshness.

This type of tooth powder is intended for routine use and must conform to specifications related to fluoride content, abrasiveness, pH, and microbial safety. The product should be:

  • Smooth and free-flowing

  • Non-irritating to oral tissues

  • Safe for regular use

  • Effectively protective against cavities

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Purpose of Testing

Testing of fluoridated tooth powder under IS 5383:2021 ensures that the product is safe, effective, and compliant with regulatory standards while delivering proven anti-cavity benefits.

Key Objectives of the Testing:

  • Determine fluoride content to ensure it is within the prescribed safe and effective limit

  • Evaluate abrasiveness to confirm that the product cleans without damaging tooth enamel

  • Measure pH (3% aqueous slurry) for mucosal safety and product stability

  • Assess foaming ability and cleansing performance

  • Verify microbial limits to ensure the product is free from harmful bacteria or fungi

  • Check for heavy metals like lead, arsenic, and mercury within permissible safety limits

  • Detect foreign matter and grittiness to avoid oral discomfort

  • Ensure labeling, composition, and packaging compliance with BIS standards

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