Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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061
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Date of Entry 12/18/2023
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FR Recognition Number
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4-316
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Standard | |
ISO 20127 Second edition 2020-08 Dentistry - Physical properties of powered toothbrushes |
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Identical AdoptionANSI ADA Standard No.120-2022 Dentistry - Physical Properties of Powered Toothbrushes |
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Scope/AbstractThis document specifies requirements and test methods for the physical properties of powered toothbrushes in order to promote the safety of these products for their intended use.
There are different technologies of powered toothbrushes. Common features of those powered toothbrushes to which this document applies are: - a battery; - a motor; - a mechanical or magnetic drive system; - a moving brush head with tufted filaments.
Powered toothbrushes can have a moving brush head with different motions (e.g. oscillating-rotating, side-by-side), frequencies and velocities. ... |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Transition Period
FDA recognition of ISO 20127 First edition 2005-03 [Rec# 4-238] will be superseded by recognition of ISO 20127 Second edition 2020-08 [Rec# 4-316]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-238] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 4-238] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.6865 |
Toothbrush, Powered
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Class 1
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JEQ
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§872.6865 |
Toothbrush, Ionic, Battery-Powered
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Class 1
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MMD
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872.6866 |
Powered Radiofrequency Toothbrush
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Class 2
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QMJ
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Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |