A brand owner should cite manual toothbrush standards, such as ISO 20126 and ANSI/ADA Standard No. 119, by full number and edition year. For the US, the specification should name the ANSI/ADA 119 edition that FDA currently recognizes. Bristle and tuft properties should be written as values with tolerances and a named test method, not as descriptive words.
This guide is for brand owners, pharmacy chains, dental distributors and dental service organizations (DSOs). It shows how a written specification, a named standard and a test document fit together before a brand owner asks a manufacturer for samples.
What are ISO 20126 and ANSI/ADA Standard No. 119?
For a brand owner, ISO 20126 and ANSI/ADA Standard No. 119 are documents to name in a specification by full number and edition year, so the specification and the test report point to the same text. A brand owner should read the scope section of the exact edition being cited to confirm what that edition covers before naming it in a specification.
A recognized consensus standard is a published technical document that a regulator has formally listed as acceptable to cite. According to the U.S. FDA Recognized Consensus Standards database, ANSI/ADA Standard No. 119 is listed as a recognized standard for manual toothbrushes.
Why reference manual toothbrush standards instead of descriptive words?
A specification line that names a property, a value and the method used to measure it can be checked on a sample, on a test report and later on production lots. The specification names which standard and edition’s test method applies, and the brand owner and the manufacturer agree the value.
Which edition of ANSI/ADA 119 should a US specification cite?
A US-market specification should name the edition that FDA currently recognizes, and the test report should name the same edition. According to the U.S. FDA Recognized Consensus Standards database, “FDA recognition of ANSI ADA Standard No. 119-2021 [Rec# 4-293] will be superseded by recognition of ANSI ADA Standard No. 119-2023 [Rec# 4-339].”
According to the same U.S. FDA Recognized Consensus Standards database entry, “FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-293] until July 4, 2027.” A declaration of conformity is a signed statement that a product meets a named standard and edition.
For a new specification, the practical step is to write the full standard number with its edition year, for example ANSI/ADA Standard No. 119-2023, rather than “ANSI/ADA 119” alone.
How is a manual toothbrush classified in the US?
According to the Legal Information Institute, Cornell Law School (21 CFR 872.6855), a manual toothbrush in the US is a Class I (general controls) device that is exempt from the premarket notification procedures in subpart E of part 807, subject to the limitations stated in the regulation.
Before relying on that classification, a brand owner should read the limitations in the regulation text against the planned product and its claims.
How should bristle and tuft properties be written measurably?
Each bristle and tuft property in a specification or purchase order should name the property, a value or grade, a tolerance where relevant, and the method used to check it. The brand owner sets the values from approved samples and the target market’s requirements; this guide does not propose target numbers.
- Filament material: name the polymer type and any grade or supplier reference agreed with the manufacturer, so a material change is visible.
- Filament diameter: state a nominal diameter with a tolerance and the unit, and say how it is measured.
- Bristle stiffness grade: state the grade label used on the pack and the test method that defines that grade, so the label is linked to a measurement.
- End-rounding expectation: end-rounding is the shaping of each filament tip into a rounded end after cutting. State how tips are inspected, the magnification or method, and the acceptance criterion as a share of inspected filaments.
- Tuft pull-out force: tuft pull-out force is the force needed to pull one tuft out of the head. State it as a minimum value, the number of tufts tested per brush, and the standard and edition whose test method applies.
- Tuft pattern and trim: reference an approved drawing for the number of tufts, their layout and the trim profile, with dimensional tolerances.
A line such as “tuft pull-out force: minimum value as agreed, tested per the named standard and edition” can be verified. A line such as “strong tufts” cannot.
What should a brand owner check on a test report or declaration of conformity?
A test report or declaration of conformity is only useful if it clearly matches the product the brand owner will sell. Check these points before accepting it:
- Standard number and edition: the full number with edition year, matching the edition named in the specification.
- Product and sample identity: the model name or code, head and handle variant, and stiffness grade of the samples tested.
- Test date: when testing was done, so it can be compared with any later design or material change.
- Who performed the test: the laboratory or party that ran the tests and signed the report.
- Results against the specification: each measured value compared with the value in the approved specification, not only a general pass statement.
If any of these points is missing or does not match, ask for clarification or a revised document before approving the product.
How do standards and specifications connect to sample approval and production checks?
The approved specification, with its named standard editions and measurable values, is the reference for sample approval and for every later production check.
Private label of existing designs
In private label, the brand owner sells a manufacturer’s existing design under the brand owner’s own label. The brand owner should ask which standard edition existing test documents cite, compare the documents with the checks above, and write the existing design’s bristle and tuft values into the brand owner’s own specification so production lots can be checked against them.
Custom OEM development
In custom OEM development, the brand owner and the manufacturer create a new or modified design from a brief. The brief should name the standard edition and the measurable properties from the start, so the first samples can be tested and approved against them. Once a sample is approved, the same values and methods become the acceptance criteria for production. The steps from brief to sample are covered in How Toothbrush OEM Development Works: From Brief to Sample.
SANGSI Co., Ltd. is an oral care manufacturer based in South Korea. SANGSI offers OEM and private label toothbrush manufacturing for brand owners and distributors.
Summary: manual toothbrush standards in a brand owner’s specification
- Reference ISO 20126 and ANSI/ADA Standard No. 119 by full number and edition year, and read the scope of the cited edition.
- For the US edition question, check the U.S. FDA Recognized Consensus Standards database entry for ANSI/ADA Standard No. 119 and name the same edition in the specification and the test report.
- According to the Legal Information Institute, Cornell Law School (21 CFR 872.6855), a manual toothbrush in the US is a Class I device exempt from premarket notification, subject to the limitations stated in the regulation.
- Write filament material, filament diameter, stiffness grade, end-rounding and tuft pull-out force as values with tolerances and named test methods.
- Check every test report or declaration for edition, sample identity, date, tester and results against the specification.
- Use the approved specification as the reference for sample approval and production checks in both private label and OEM development.
