| ISO 20127 First edition 2005-03-15 Dentistry - Powered toothbrushes - General requirements and test methods |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 4-238 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
| FDA Tech | Michael Adjodha FDA/OMPT/CDRH/ODE/DAGID/DEDB 301-796-6276 michael.adjodha@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 International Standard is applicable to brackets and tubes for use in fixed orthodontic appliances.
This International Standard gives details of methods to compare the functional dimensions of orthodontic brackets and tubes, the test methods by which they can be determined, as well as packaging and labelling information.
This International Standard does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993-1 and ISO 7405.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.6865 | Toothbrush, Ionic, Battery-Powered | Class 1 | MMD |
| §872.6865 | Toothbrush, Powered | Class 1 | JEQ |
| There is no relevant guidance published at this time. |