Orthodontic Brackets in Canada vs the US: Which Class Applies?

Quick facts

• An orthodontic bracket is the bonded attachment that holds an archwire to a tooth and carries the force that moves the tooth.
• In the United States the material splits the class: a metal bracket files under 21 CFR 872.5410, Orthodontic appliance and accessories, at Class I, while a plastic or ceramic bracket files under 21 CFR 872.5470, Orthodontic plastic bracket, at Class II.
• The openFDA classification API lists EJF (Bracket, Metal, Orthodontic), NQS (Bracket, Metal, Orthodontic, Reprocessed), DYW (Bracket, Plastic, Orthodontic) and NJM (Bracket, Ceramic, Orthodontic).
• In Canada Rule 3(a) of Schedule 1 reads: "all denture materials and orthodontic appliances, and their accessories, are classified as Class II". A bracket is an orthodontic appliance, so it is Class II in Canada whatever the material.
• The words Despite rules 1 and 2 open Rule 3, so the material or body-contact rules do not move the class - the appliance rule fixes it.
• Entries, classes and product codes below were checked against the eCFR, the Regulations and the openFDA classification database on 2026-10-12.

An orthodontic bracket is small, cheap and the whole point of fixed appliances: it is the attachment bonded to a tooth that holds the archwire. Practices buy them by the thousand in metal, plastic and ceramic, and the choice is usually clinical or aesthetic. Regulation adds a wrinkle that buyers do not expect - in the United States the material changes the class, and in Canada it does not. This article sets out both routes and the standards behind them. The three-layer dental bibs used at the same bonding appointment are ordered with the same clinic consumables list.

What is an orthodontic bracket?

A bracket is the bonded attachment fixed to a tooth that carries the archwire and translates its force into tooth movement. Metal brackets are stainless steel; aesthetic brackets are polycarbonate or ceramic; self-ligating designs carry an integral clip instead of a ligature. The archwire, the bands and the tubes that complete the appliance are accessories to the same system.

Most of these brackets are used once and removed at debond. A subset - the metal and the plastic families - can be reprocessed and reused, and those carry their own product codes (NQS for a reprocessed metal bracket, NLC for a reprocessed plastic one). The class follows the bracket and its stated use, not whether it was used before.

The bracket also fixes the appointment, not just the tooth. A clinic stocks brackets by slot size and prescription, matches them to the case, and commits the archwire sequence to the chart. The regulatory question a purchasing officer has to answer is narrower but real: which class does the item on the order carry, and does the supplier's licence match it.

What are the US entries for a bracket?

21 CFR 872.5410, Orthodontic appliance and accessories, is a Class I entry; the openFDA classification API lists EJF (Bracket, Metal, Orthodontic), NQS (Bracket, Metal, Orthodontic, Reprocessed), DZC (Wire, Orthodontic), DYO (Band, Material, Orthodontic) and ECM (Band, Preformed, Orthodontic) under it. 21 CFR 872.5470, Orthodontic plastic bracket, is a Class II entry, covering DYW (Bracket, Plastic, Orthodontic), NJM (Bracket, Ceramic, Orthodontic) and NLC (Bracket, Plastic, Orthodontic, Reprocessed).

That is the surprise for a practice that orders a mixed kit: the metal and the ceramic brackets in the same box come from two different regulation numbers, at two different classes. It does not stop the kit being used together - the class is a manufacturer and distributor concern - but it explains why some brackets carry more data behind them than others.

Bracket	US regulation	US class	Product code
Metal bracket	21 CFR 872.5410	I	EJF
Metal bracket, reprocessed	21 CFR 872.5410	I	NQS
Plastic bracket	21 CFR 872.5470	II	DYW
Ceramic bracket	21 CFR 872.5470	II	NJM

How does Canada classify a bracket?

Canada applies Schedule 1 of the Medical Devices Regulations. Rule 3 opens with "Despite rules 1 and 2" and then reads: "(a) all denture materials and orthodontic appliances, and their accessories, are classified as Class II". A bracket is an orthodontic appliance, so its class is Class II in Canada whether it is metal, plastic or ceramic.

This is the cleanest example of a rule that overrides the material rules. Rule 2 would otherwise ask whether the bracket contacts mucosa; Rule 3 declares the answer irrelevant for an orthodontic appliance and fixes the class at II. So a Canadian buyer sees one class where a US buyer sees two.

Item	Canada	United States
Named entry	None; classified by rule	872.5410 (metal) / 872.5470 (plastic, ceramic)
Class, metal bracket	Class II (Rule 3(a))	Class I (general controls)
Class, plastic or ceramic bracket	Class II (Rule 3(a))	Class II
Governing text	Schedule 1, Rule 3(a)	21 CFR 872.5410 / 872.5470
Route to market	Device licence s.32 with ISO 13485	Registration for Class I; 510(k) for Class II

Which orthodontic components share a class?

Brackets, bands, archwires, tubes, springs, ligature clamps and preformed bands are all orthodontic appliances and accessories. In the United States the metal accessories sit at Class I and the plastic and ceramic brackets at Class II; in Canada all of them are Class II under Rule 3(a).

Component	Typical use	Class, Canada	Class, US
Metal bracket	Standard fixed appliance	II (Rule 3(a))	I (872.5410)
Plastic bracket	Aesthetic fixed appliance	II (Rule 3(a))	II (872.5470)
Ceramic bracket	Aesthetic fixed appliance	II (Rule 3(a))	II (872.5470)
Archwire, band, tube	Appliance components	II (Rule 3(a))	I (872.5410)

The detail a practice should carry into a reprocessing decision is the reused bracket. If a clinic reprocesses brackets rather than using new ones, the reprocessing must follow the manufacturer's written instructions - which is where ISO 17664 sits - and the bracket's own product code should reflect that it is a reprocessed device.

What does the class difference change for the manufacturer?

It changes the paperwork, not the chairside use. A Canadian supplier of a metal bracket holds a Class II device licence under section 32 of the Regulations, built on ISO 13485 quality management and ISO 14971 risk management. In the United States the same metal bracket is a Class I device that reaches the market under general controls, while the ceramic bracket needs a 510(k).

For the practice the visible difference is small and worth knowing. The instructions for use name the bonding procedure and, where relevant, the reprocessing steps. A clinic that follows them is working inside the cleared use; one that invents its own bonding or cleaning method is not.

That difference shows up in the supplier's paperwork, which a clinic can ask to see. A Canadian supplier of any bracket should be able to name the device licence that covers the item and the ISO 13485 certificate behind it. A US supplier should be able to state whether the item reached the market by registration or through a 510(k). Those are two questions a practice can ask before it commits to a bracket system for a year, and the answer tells it whether the kit is supplied as described.

Which standards apply to an orthodontic bracket?

The general medical-device standards apply: ISO 13485 for quality management and ISO 14971 for risk management. Where a bracket is reprocessed, the manufacturer's processing information is governed by ISO 17664. Ontario practices add the reprocessing rules in the RCDSO standards and guidelines, and the general infection-control framework from Public Health Ontario.

What should the order record say?

Record the bracket type and material, the slot size and prescription, the quantity, the lot and the expiry. Add the class reference - 21 CFR 872.5410 for a metal bracket or 872.5470 for a plastic or ceramic one in the United States, Rule 3(a) of Schedule 1 in Canada - so a reviewer can see why the Canadian order shows one class and the US order shows two.

An orthodontic clinic turns over chair-side consumables every week. Clinics that stock for a whole practice can order through the wholesale programme and request a bulk quote for a standing or annual order; the cotton rolls, 2 medium sits in the same catalogue. Reselling? become a distributor.

Sources

1. openFDA device classification API
2. Medical Devices Regulations, SOR/98-282, full text and Schedule 1
3. US FDA, overview of device regulation
4. US FDA, medical device databases
5. Health Canada, medical devices
6. Health Canada, establishment licensing
7. Royal College of Dental Surgeons of Ontario, standards and guidelines
8. Canadian Dental Association
9. Public Health Ontario, infection prevention and control
10. CSA Group
11. International Electrotechnical Commission
12. ISO 17664:2017, processing of health care products — information to be provided
13. ISO 13485:2016, medical devices quality management
14. ISO 14971:2019, risk management of medical devices

Printable record sheet. An ortho clinic turns over brackets, bands and wires fast, and its supply record should keep up. Open the free sterilization log sheet library — the downloadable pack holds a steam-cycle log, a reprocessing-room checklist and an equipment-maintenance sheet. No account and no sign-up; print as many copies as your autoclave log needs.

Log generator. Because a dated stock and reprocessing log is what keeps ortho supply auditable. Run the sterilization log generator to build a dated, facility-labelled cycle sheet you can print or file straight into your quality manual.

Ask a compliance specialist. If you are an orthodontic practice and want a written answer on how the Canadian class for your brackets differs from the US one. Send your question — you get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.

Related reading

• Orthodontic bands in Canada vs the US: which class applies
• Dental bonding agents in Canada vs the US: which class applies

CliniEco Medical supplies eye care, laboratory and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, laboratory and dental procurement professionals and is not legal advice; the class of a device and the records a practice keeps belong to the manufacturer and to the requirements that apply to it.

Frequently Asked Questions

What class is an orthodontic bracket in the United States?

It depends on the material. A metal bracket is Class I under 21 CFR 872.5410; a plastic or ceramic bracket is Class II under 21 CFR 872.5470.

Why is a bracket always Class II in Canada?

Rule 3(a) of Schedule 1 states that all denture materials and orthodontic appliances, and their accessories, are Class II. A bracket is an orthodontic appliance, so its class does not depend on the material.

What else is this called?

Bracket, bonded attachment, fixed appliance attachment, metal bracket, ceramic bracket, self-ligating bracket and aesthetic bracket all describe the same family.

Are archwires and bands in the same class?

In the United States the metal accessories file at Class I under 21 CFR 872.5410; in Canada they are Class II with the brackets under Rule 3(a).

Do reprocessed brackets have a different class?

No. Reprocessing does not change the class; it changes the product code. A reprocessed metal bracket is listed under NQS, a reprocessed plastic one under NLC.

Do I need a licence to import brackets into Canada?

A Class II device needs a device licence under section 32 of the Medical Devices Regulations, held by the manufacturer, with an ISO 13485 quality certificate behind it.