Quick facts
- Both countries: the product category is defined by a single international standard, ISO 28399:2021, which sets requirements and test methods for external tooth whitening products intended for both professional and home use.
- Both countries: the toothpaste and dentifrice side sits in ISO 11609:2017, which covers physical and chemical properties, test methods and marking, labelling and packaging.
- United States: the fluoride monograph writes a numeric content limit into the text. 21 CFR 355.10 sets a preventive treatment gel as stannous fluoride at 0.4 per cent in an anhydrous glycerin gel, and a treatment rinse as a concentrate diluted to 0.1 per cent.
- United States: 21 CFR 355.20 caps the total fluorine in a package, at 276 mg for a dentifrice and 120 mg for a preventive treatment gel or rinse, with an exemption for products marketed for professional office use only.
- United States: a resin-based tooth material used to restore a tooth is a device, reached through 21 CFR 872.3690 and placed in Class II, which shows that the framework follows the intended use rather than the product name.
- The standard and regulation texts cited here were retrieved 2026-10-03; the Canadian regulation text is current to 2026-09-21.
A whitening product is a gel, a tray, a strip, a pen or a paste, and it can be sold to a clinic or to a household. The same active material can be described as a professional product, a home product or a cosmetic depending on what the label claims it does. That is why the specification for the category is written as a product standard rather than as a device listing: the standard describes the product, and the framework routes it by what it is claimed to do.
Does one standard cover professional and home whitening products?
Yes, and the fact that it does is the reason a clinic and a household can be specified against the same document.
ISO 28399:2021 sets out requirements and test methods for external tooth whitening products for both professional and home use. The two channels are covered by one standard rather than two, which means a specification can name the standard and then state which use the product is intended for. A professional product and a home product are not two categories; they are two intended uses of one category.
The toothpaste side is separate. ISO 11609:2017 covers the physical and chemical properties of toothpaste and, importantly for a buyer, the marking, labelling and packaging. A whitening toothpaste is a dentifrice with a whitening claim, so the dentifrice standard governs the base and the claim is handled by the labelling rules.
For a Canadian clinic, naming both standards in the product file is stronger than naming either alone, because one covers the active whitening product and the other covers the paste it may be used with.
| Item | Canada | United States |
|---|---|---|
| Product standard for whitening | ISO 28399:2021, professional and home | ISO 28399:2021, professional and home |
| Product standard for toothpaste | ISO 11609:2017, properties and labelling | ISO 11609:2017, properties and labelling |
| Route to the class for a gel | The intended use stated on the label | The intended use stated on the label |
| Route to the class for a restorative resin | Not a named entry | 872.3690, Class II |
| Where a numeric content limit sits | Set by the applicable framework | Written into the monograph at 355.10 |
What does the American monograph cap?
Two package numbers, and they are the clearest written limits in the category.
21 CFR 355.10 sets the active content for a preventive treatment gel: stannous fluoride at 0.4 per cent in an anhydrous glycerin gel. The same section sets a treatment rinse as a concentrate that is diluted with water to a 0.1 per cent aqueous solution before use. These are content limits, not claims.
21 CFR 355.20 then caps the total fluorine a package may contain: a dentifrice package "shall not contain more than 276 mg total fluorine per package", and a preventive treatment gel or treatment rinse package is capped at 120 mg. The section also states the exemption that matters to a clinic: a product "marketed for professional office use only and labeled in accord with" the professional labelling section is exempt from those caps.
That exemption is the clinic-relevant fact. A professional-office product and a retail product can carry the same active and be treated differently at the packaging level, so a clinic that buys a professional product should record the professional-office labelling that makes the exemption apply.
| Provision | Scope | Limit or condition |
|---|---|---|
| 355.10(c) preventive treatment gel | Active content | Stannous fluoride 0.4 per cent, anhydrous glycerin gel |
| 355.10(c) treatment rinse | Active content | Concentrate diluted to 0.1 per cent in water |
| 355.20 dentifrice packing | Total fluorine per package | Not more than 276 mg |
| 355.20 gel and rinse packing | Total fluorine per package | Not more than 120 mg |
| 355.20 professional exemption | Office-use products | Exempt when marketed for professional office use only and labelled accordingly |
Why is a restorative resin a device when a whitening gel is not listed?
Because the framework classifies by the intended use in the identification paragraph, and a resin that restores a tooth is described by that use.
21 CFR 872.3690 describes a tooth shade resin material as a device "composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth", and places it in Class II. The sentence is the class: the material is defined by what it is used for.
A whitening product is not reached by a named device entry, and that absence is itself informative. The framework routes it by its claim, and the standard that describes the product is the ISO standard rather than a device section. A buyer who expects a whitening gel to have a device entry is looking for something the framework does not provide.
The Canadian side follows the same logic through the general rules. Schedule 1 to the Medical Devices Regulations classifies a device by its intended use, so a product sold to a professional office as a device is described by that use, while a product sold as a home-care preparation is described by its own use. The intended use on the label is the field that decides.
What has to be recorded for a whitening product?
Six records, and the two that most often go missing are the intended use and the professional labelling.
- The intended use. Professional office use or home use, stated on the file rather than inferred from the strength of the product.
- The product standard cited. ISO 28399 for the whitening product and ISO 11609 where a dentifrice is used with it.
- The active content. The active and its concentration, recorded as the label states it.
- The professional labelling. The basis on which an office-use product is treated as such, kept with the batch record.
- The batch and expiry. Recorded per product, because the expiry belongs to the product and not to the tray it is delivered in.
- The tray or applicator. The delivery device recorded separately from the gel, since the two are different items in the file.
Which consumables does a whitening appointment restock?
A whitening appointment consumes isolation and barrier items on the same cycle as a hygiene appointment. For clinics and multi-site groups buying at case level, the wholesale ordering page sets out account and case terms, and the B2B wholesale collection lists the lines held for institutional buyers. The cotton rolls cover moisture control at the field, the dental bibs cover the chairside surface, and a clinic that also runs its own steriliser can pair the monitoring collection with the biological indicator 5-pack trial.
Sources
- ISO 28399:2021, external tooth whitening products
- ISO 11609:2017, toothpaste requirements and labelling
- 21 CFR 355.10, anticaries drug products for over-the-counter use
- 21 CFR 355.20, packing of anticaries drug products
- 21 CFR 872.3690, tooth shade resin material
- 21 CFR 872.3770, temporary crown and bridge resin
- 21 CFR 872.6300, rubber dam and accessories
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- Canadian Dental Association, fluoride position statement
- ISO 13485:2016, medical device quality management systems
- ISO 14971:2019, risk management of medical devices
- ISO 17664-1:2021, information for reprocessing
- Royal College of Dental Surgeons of Ontario
- Health Canada, medical devices
- Health Canada, drug and health product portal
- openFDA device classification API
- World Health Organization, oral health
- CCOHS, OSH answers
- Public Health Ontario, laboratory services test index
- College of Medical Laboratory Technologists of Ontario
A whitening product file is only as strong as the claim it is built on. The printable product and batch log is a free sheet with a column for the intended use and a column for the active content, so a professional product and a home product never share one line. The generator sized to a chairside practice builds the sheet from the number of appointments a practice books and the products it holds, which keeps a two-chair clinic from being handed a hospital form. No account and no sign-up are needed to open either one.
Where the intended use of a product needs to be written down for a supplier question, the written answer is the one worth having. Ask a compliance specialist and a written answer comes back specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Dental Whitening Trays in Canada vs the US: Which Route Applies
- Stannous Fluoride in Canada vs the US: Which Form and Rules
- Professional Fluoride Application in Canada vs the US: Which Form Applies
CliniEco Medical supplies laboratory, eye care and dental consumables of the kind described in this article. MDEL #35334. This article is written for dental, infection control and procurement professionals and is not safety or regulatory guidance; the acceptance of a product and its documentation belong to the practice's quality system and to the requirements that apply to it.
Frequently Asked Questions
Is there a standard for tooth whitening products?
Yes. ISO 28399:2021 sets requirements and test methods for external tooth whitening products intended for professional and home use, so one standard covers both channels.
Does the American fluoride monograph limit whitening or treatment products?
Section 21 CFR 355.20 caps the total fluorine in a package at 276 mg for a dentifrice and 120 mg for a preventive treatment gel or treatment rinse, with an exemption for products marketed for professional office use only and labelled accordingly.
Why does a whitening gel not have its own device entry?
The framework classifies a device by the intended use described in its entry, and a whitening product is routed by the claim it carries rather than by a named device section. A resin used to restore a tooth is different, and section 872.3690 describes it as a Class II device.
What content does the monograph set for a treatment gel?
Section 355.10 sets a preventive treatment gel as stannous fluoride at 0.4 per cent in an anhydrous glycerin gel, and a treatment rinse as a concentrate diluted to a 0.1 per cent aqueous solution.
Which standards should a clinic cite for a whitening product?
Cite ISO 28399:2021 for the whitening product and ISO 11609:2017 where a toothpaste is used with it, and record the intended use and the active content on the product file.
Is a professional product treated the same as a retail product?
Not at the packaging level. The professional exemption in section 355.20 applies to a product marketed for professional office use only and labelled in accord with the professional labelling section, so a clinic should keep that labelling with the batch record.
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