| ANSI ADA Standard No. 119-2015 Manual Toothbrushes |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 4-236 |
| Extent | Complete standard |
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| STG | Dental/ENT |
| FDA Tech | Mary (Susan) Runner FDA/OMPT/CDRH/ODE/DAGID/DEDB/ 301-796-6282 susan.runner@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard describes requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use. Also specified is a test method for determining the resistance of the tufted portion of manual toothbrushes to deflection. This test method is applicable to toothbrushes having a conventional, flat trim design and may not be applicable to toothbrushes with other designs. Specifically excluded from this standard are manual interdental brushes and powered oral hygiene devices as these instruments are covered by separate standards.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.6855 | Toothbrush, Manual | Class 1 | EFW |
| There is no relevant guidance developed at this time. |