Written and maintained by CASRAI Editorial Board
Last updated
General product information, not medical or dental advice. Questions about an individual’s oral health belong with a dentist.
Short answer
A manual toothbrush is a hand-held brush with a shaft and natural or synthetic bristles at one end, used to remove plaque and food debris from the teeth. In the United States, FDA regulates it as a Class I device under 21 CFR 872.6855 (product code EFW), exempt from 510(k) premarket notification. The American Dental Association (ADA) advises a soft-bristled brush, replaced every three to four months or sooner if the bristles fray.
Definition and scope
The federal definition is short. 21 CFR 872.6855 identifies a manual toothbrush as “a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.” The definition says nothing about handle shape, head size, bristle count or bristle stiffness; those are manufacturer design choices, not regulatory categories.
The same regulation covers only the hand brush used on natural teeth. Brushes made for other cleaning jobs are handled elsewhere on this site: see denture brushes for appliance cleaning and interdental brushes for the spaces between teeth.
How FDA classifies the device
The table lists what the FDA product classification record and the regulation text state for this device. Checked 2026-10-30.
| Item | What the source states | Source |
|---|---|---|
| Device name and product code | “Toothbrush, Manual”, product code EFW | FDA Product Classification database; openFDA device classification |
| Regulation number | 21 CFR 872.6855 | eCFR; FDA Product Classification database |
| Device class | Class I (general controls) | 21 CFR 872.6855(b) |
| Premarket notification | Exempt from 510(k) (subpart E of part 807), subject to the limitations in 21 CFR 872.9 | 21 CFR 872.6855(b) |
| Quality management system | If not labeled or represented as sterile, exempt from the part 820 manufacturing requirements except records and complaint-file requirements (820.35) | 21 CFR 872.6855(b) |
Class I devices are subject to general controls, the baseline requirements that apply to all medical devices; the wider classification and pathway framework is explained in FDA medical device regulations: classification, 510(k) and PMA.
How it is used in practice
The ADA’s consumer guidance (MouthHealthy, checked 2026-10-30) covers the brush itself:
- Bristle softness. The ADA recommends a soft-bristled brush and says firm or even medium bristles “may cause damage to your gums and enamel.”
- Replacement. The ADA advises replacing the toothbrush every three to four months, or sooner if the bristles are frayed.
- Cleaning and storage. The ADA advises rinsing with tap water, storing the brush upright to air dry, keeping brushes that share a holder separated, and not routinely covering brushes or storing them in closed containers.
For how oral care is handled in hospital infection prevention, see ventilator-acquired pneumonia.
Manual and powered toothbrushes
The ADA states that “both types of toothbrush can effectively and thoroughly clean your teeth” and treats the choice as a matter of personal preference.
The Cochrane review of powered versus manual toothbrushes (Yaacob et al., CD002281, published 17 June 2014, searches to 23 January 2014) pooled 51 of 56 trials (4,624 participants in the meta-analysis). Powered brushes showed moderate-quality evidence of less plaque (11% at one to three months, 21% beyond three months on the Quigley Hein index) and less gingivitis (6% and 11% on the Loe and Silness index). The authors wrote that the clinical importance of these findings remains unclear.
Where it matters for labs, clinics and supply decisions
Product listings use “toothbrush” for items with different legal identities. A supply or compliance reviewer can use the sourced points below as a checklist of what is, and is not, defined.
| Check | What a source defines |
|---|---|
| Is it a manual toothbrush under FDA? | A shaft with natural or synthetic bristles at one end, intended to remove plaque and food debris from teeth (21 CFR 872.6855) |
| Regulatory class and 510(k) | Class I; exempt from 510(k) subject to 21 CFR 872.9 |
| Is the item represented as sterile? | The quality-system exemption applies only if it is not labeled or represented as sterile (21 CFR 872.6855(b)) |
| Bristle retention and handle strength | The ADA Seal of Acceptance means an independent ADA panel evaluated that bristles will not fall out with normal use and that the handle stays strong |
| Bristle stiffness | ADA guidance: soft |
| Replacement interval | ADA guidance: every three to four months, or sooner if frayed |
| Head size, shape, bristle count | Not defined by the regulation or by the ADA guidance; check the manufacturer’s labeling |
Common misunderstandings
- “Firmer bristles clean better.” The ADA advises soft bristles for manual and powered brushes alike, because firmer bristles may damage gums and enamel.
- “A powered brush is always better.” The ADA calls the choice a wash; the Cochrane review found modest plaque and gingivitis differences whose clinical importance the authors called unclear.
- “A toothbrush is not regulated.” It is a Class I medical device with its own regulation and product code. Class I and 510(k) exemption describe the level of FDA control, not an absence of it.
- “The ADA Seal is a legal requirement.” The Seal is a voluntary evaluation by the ADA Council on Scientific Affairs; it is separate from FDA classification.
FAQ
What is a manual toothbrush?
A hand-held device with a shaft and natural or synthetic bristles at one end, intended to remove adherent plaque and food debris from the teeth (21 CFR 872.6855).
Does FDA regulate manual toothbrushes?
Yes. They are Class I devices (product code EFW) and exempt from 510(k) premarket notification, subject to the limitations in 21 CFR 872.9.
How often should a manual toothbrush be replaced?
The ADA advises every three to four months, or sooner if the bristles are frayed.
Should the bristles be soft or firm?
The ADA advises soft bristles; firm or medium bristles may damage gums and enamel.
How should a toothbrush be stored?
Rinse with tap water, store upright and allow to air dry, as the ADA advises.
Sources
- eCFR, 21 CFR 872.6855 Manual toothbrush. ecfr.gov. Checked 2026-10-30.
- FDA, Product Classification database, product code EFW. accessdata.fda.gov. Checked 2026-10-30.
- American Dental Association, MouthHealthy: Toothbrushes. mouthhealthy.org. Checked 2026-10-30.
- Yaacob M et al., Powered versus manual toothbrushing for oral health, Cochrane Review CD002281 (2014). cochrane.org. Checked 2026-10-30.
