Quick facts
- United States: dental floss has its own regulation. 21 CFR 872.6390 covers "dental floss" and classifies it as a Class I device.
- United States: the entry is specific about the product: it describes a string-like device of cotton or other fibers intended to remove plaque and food particles from between the teeth to reduce tooth decay, and notes that the fibers may be coated with wax.
- United States: the device is exempt from premarket notification, subject to the limitations in 872.9.
- Canada: there is no named floss entry. Floss reaches Class I either as a dental instrument under Schedule 1, Rule 3(b), or as a non-invasive device under Rule 7(1), and the class is Class I either way.
- Both countries: floss is a Class I product with no premarket submission and no class that rises with the addition of wax or a flavour coating.
- Both countries: the technical requirements for an integrated floss and handle come from ISO 28158, which sets a static load test for the handle.
Dental floss is the least regulated product in the dental catalogue, and that is the point of writing it down. Both countries place it in Class I, both allow it to market without a premarket submission, and both leave the performance question to a product standard rather than to a regulation. The result is a product that a clinic buys without a second thought and a class file that should still exist. This article sets out the American entry, the Canadian route, the standard behind an integrated floss pick, and the records an order should carry.
How do Canada and the United States classify dental floss?
The United States names the product. 21 CFR 872.6390 is headed "Dental floss," and its identification paragraph reads: "Dental floss is a string-like device made of cotton or other fibers intended to remove plaque and food particles from between the teeth to reduce tooth decay. The fibers of the device may be coated with wax for easier use." The classification paragraph places it in Class I and exempts it from premarket notification, subject to the limitations in 872.9.
Canada does not name it. The Medical Devices Regulations classify devices by rule, and floss reaches Class I through one of two doors. Rule 3(b) states that "all surgical or dental instruments are classified as Class I," which covers floss characterised as a dental instrument. Alternatively, floss is a non-invasive device, and Rule 7(1) places "all other non-invasive devices" in Class I. The class is Class I under either reading, and no product-specific section is created for it.
The structural difference matters to a buyer for one reason. In the United States, a supplier can point to a numbered section and quote it. In Canada, the supplier points to a rule. Both produce the same class, and only one produces a citable section number.
| Item | Canada | United States |
|---|---|---|
| Named entry | None | 21 CFR 872.6390, dental floss |
| Product code | Not applicable | JES, dental floss |
| Class | Class I, Rule 3(b) or Rule 7(1) | Class I |
| Premarket notification | Not applicable | Exempt, subject to 872.9 |
| Wax coating | Does not change the class | Does not change the class |
| Integrated floss and handle | Class I, with ISO 28158 as the product standard | Class I, with ISO 28158 as the product standard |
What does ISO 28158 require of an integrated floss pick?
ISO 28158 covers integrated dental floss and handles, the floss pick that a patient holds rather than winds around a finger. The standard sets requirements and test methods for the product, and one requirement is worth quoting because it is the kind of figure a supplier claim rarely states: the integrated dental floss and handle "shall withstand the static load of 10 N for 10 s without a breakage of the floss or handle, a pull-out of the floss from the handle or displacement of more than 10 mm of the loading point in the direction of the loading."
That sentence describes the failure modes a clinic actually sees — a floss that snaps at the fork, a floss that pulls out of the handle, a handle that flexes until the loading point moves. A clinic that stocks floss picks for patient education can ask a supplier whether the product is tested to that requirement, and the answer is a stronger fit question than a description of the floss material.
| Product form | What the standard addresses | What the record should show |
|---|---|---|
| Loose floss, waxed or unwaxed | Fibre type and coating | Material and coating, class position |
| Floss pick, integrated handle | Static load, pull-out, displacement | ISO 28158 reference and test result |
| Interdental brush | Handle and bristle fit | Product type and size range |
| Floss with a flavour coating | Coating, not a class change | Coating recorded as a label claim |
Does a wax coating change the class in Canada or the United States?
No, in either country. The American entry mentions a wax coating inside the identification paragraph and does not create a separate class for it, and the Canadian rules classify the product by what it is rather than by what it is coated with. Wax, flavour and whitening coatings are label features; they do not move floss out of Class I, and they do not introduce a premarket requirement.
What a coating can do is create a claim. A floss that is marketed for a therapeutic effect beyond plaque removal — for example, to treat a named gum condition — is moving from a product description into a treatment claim, and a treatment claim is the kind of statement that changes how a regulator reads the product. The safe file keeps the coating in the ingredients and the claim out of the copy.
What should a practice record for a dental floss order?
Five records, each tied to a requirement.
- The product description. Loose floss or an integrated pick, in the words the supplier uses, because the two forms reach the same class by slightly different reasoning.
- The standard reference. Where the line is an integrated floss and handle, the ISO 28158 reference and the test result.
- The material and coating. Fibre type and any wax, flavour or whitening coating, recorded as a label feature.
- The class position. Class I in both countries, with the route recorded — the named entry in the United States, Rule 3(b) or Rule 7(1) in Canada.
- The claim review. A check that the copy describes plaque removal and does not assert treatment of a condition.
How should floss be stored and dispensed in a clinic?
Floss is a small consumable with a long shelf life and a short working life once it is out of the packet. The two things that matter in a clinic are the storage condition and the dispensing pattern. Floss stored in a warm, humid area and taken from a bulk carton without a rotation rule is the item that is found expired or contaminated at the annual tidy-up, and neither problem costs much to prevent.
Three habits cover the clinic stock. The first is a rotation rule, so that the oldest carton is used first and the expiry date on the pack is visible rather than buried at the back. The second is a dry storage location, away from the sterilizer and away from a sink, because both raise the humidity around the stock. The third is a dispensing point that keeps the individual packets closed until use, since an open carton of loose floss is exposed to the air of the room.
For a practice that gives floss to patients, the same rules apply to the patient-education stock, and the ISO 28158 reference for an integrated floss and handle belongs on the specification rather than on the handout. The patient needs the instruction; the file needs the standard reference; keeping the two apart keeps both accurate.
Which consumables sit beside the floss line on a dental order?
Dental consumables are ordered as a cycle, and the floss line travels with the isolation and chairside consumables that share the same order. For practices 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 CliniEco dental range gathers the oral hygiene and isolation consumables, and a practice that wants the floss and hygiene lines together can start from the waxed dental floss three-pack, the cordless water flosser or the biological indicator five-pack trial for practices that also run their own sterilizer.
Sources
- 21 CFR 872.6390, dental floss
- 21 CFR 872.9, limitations on exemptions
- openFDA device classification API
- FDA device classification database, dental floss
- 21 CFR 872.6010, abrasive device and accessories
- ISO 28158:2018, integrated dental floss and handles
- Medical Devices Regulations, SOR/98-282
- Medical Devices Regulations, section index
- Health Canada, medical devices
- Health Canada, drug and health product portal
- Medical Devices Active Licence Listing
- Royal College of Dental Surgeons of Ontario
- Canadian Dental Association
- American Dental Association
- ADA, science and research institute
- ISO 13485:2016, medical devices quality management
- ISO 15189:2022, medical laboratories
- Public Health Ontario, infectious diseases
- CCOHS, OSH answers index
- WHO, oral health
Print-ready companion: the free sterilization log sheet keeps the day’s cycle records in one printable place, with no account and no sign-up.
Retail consumables and clinical loads share the same logbook. The sterilization log generator prints the cycle sheet a dental clinic files after each day of reprocessing.
Not sure how this applies to your own setup? Ask a compliance specialist — you’ll get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Tongue Scrapers in Canada vs the US: Which Class Applies?
- Night Guards in Canada vs the US: Which Class Applies?
- Disposable Tooth Brushes in Canada vs the US: Which Single-Use Rules?
CliniEco Medical supplies eye care, laboratory and clinic consumables of the kind described in this article. MDEL #35334. This article is written for dental, laboratory and procurement professionals and is not dental, medical or regulatory advice; the classification of a specific product and the claims made for it belong to the manufacturer and to the requirements that apply in the destination market.
Frequently Asked Questions
What class is dental floss in the United States?
Class I. It has its own entry, 21 CFR 872.6390, which describes the product and exempts it from premarket notification subject to the limitations in 872.9.
What class is dental floss in Canada?
Class I. It reaches that class either as a dental instrument under Schedule 1, Rule 3(b), or as a non-invasive device under Rule 7(1).
Does a wax coating change the classification?
No. The US entry mentions the wax coating inside the same identification paragraph, and the Canadian rules classify the product by what it is rather than by its coating.
Which standard covers an integrated floss pick?
ISO 28158 covers integrated dental floss and handles. It sets a static load requirement of 10 newtons for 10 seconds, among other test methods.
Can a floss claim move the product into another class?
A claim about treating a named condition moves the product from a description into a treatment claim, which changes how a regulator reads it. Keeping the claim to plaque removal keeps the product in Class I.
Why keep a file for a Class I product?
Because the class position and the standard reference are what a supplier or an inspector asks for, and a Class I product with no file has no evidence behind it.
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