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Orthodontic Bracket: What It Is, Types and FDA Class

An orthodontic bracket holds the archwire on a tooth. Types by material and ligation, how it differs from a band, and its Class I status under 21 CFR 872.5410

Written and maintained by CASRAI Editorial Board

Last updated

General product information only, not medical or dental advice. Treatment decisions belong to the patient’s dentist or orthodontist.

Short answer

An orthodontic bracket is a small attachment affixed to a tooth that holds an archwire; the wire, threaded through slots in the brackets, is what moves the teeth. In U.S. device regulation the only bracket named is the “orthodontic metal bracket,” a Class I (general controls) device that is exempt from premarket notification, subject to the limitations in 21 CFR 872.9.

Definition and scope

The American Association of Orthodontists (AAO), checked 2026-10-30, describes traditional braces as “a combination of brackets and wires affixed to your teeth.” The American Dental Association’s MouthHealthy page, checked the same day, describes “small brackets cemented to your teeth” that are connected by a wire which is periodically tightened. The bracket is therefore the part that stays on the tooth and gives the wire something to sit in.

This page covers what a bracket is, how it differs from related parts, and how it is identified in a regulatory record. It does not cover how appliances are placed, adjusted or removed, which is clinical work for a licensed provider.

How brackets work with archwires

The AAO’s archwire page states that archwires fit into the slots in the brackets and are responsible for actually moving the teeth. Together with the ADA description, the division of labour is simple: the bracket holds, the archwire moves. Some brackets add a mechanism to keep the wire seated; the AAO describes self-ligating brackets as having “built-in clips or doors to hold the wire.”

Types of brackets

Brackets are described along independent axes, which is why one product can fall into two categories at once. All rows below come from the AAO braces page (checked 2026-10-30) unless noted.

Axis Type What the source says
Material Metal Traditional metal braces use metal brackets affixed to the teeth, with wires threaded through them (AAO). The ADA notes brackets “may be metal or tooth colored.”
Material Ceramic “Tooth-colored or clear brackets,” made from ceramic or porcelain (AAO).
Wire retention Self-ligating Brackets with built-in clips or doors to hold the wire; the AAO notes they can be made from metal such as stainless steel, or from ceramic.
Position Lingual Mounted on the back sides of the teeth (AAO); the ADA likewise notes that in some cases they are placed “behind your teeth.”

The practical point of the table is that material and ligation are separate choices: a self-ligating bracket is not a third material, and a ceramic bracket can be self-ligating.

Where it matters for labs, clinics and supply decisions

For anyone cataloguing or reviewing dental supplies, the regulatory identity of the product is a useful reference point. 21 CFR 872.5410, “Orthodontic appliance and accessories” (checked 2026-10-30 on eCFR), identifies the device as one “intended for use in orthodontic treatment” that is “affixed to a tooth so that pressure can be exerted on the teeth.” Its list of included devices reads: preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.

The classification paragraph of the same section reads “Class I (general controls)” and states the device “is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.” Three things follow from the text itself:

  • The regulation names a metal bracket specifically. Other bracket materials, such as ceramic, are not separately named in this section.
  • The bracket is listed alongside the band, wire, tube and spring, so a catalogue that groups “orthodontic appliances and accessories” is following the regulation’s own grouping.
  • The section contains no bracket-specific performance provisions; the controls that apply are the general controls that come with Class I.

Bracket, band and separator are different items

The same regulation lists the band and the bracket as separate named devices. CASRAI covers the neighbouring items separately: see orthodontic bands and orthodontic separators (spacers), and for the appliance worn after braces, orthodontic retainer types.

Common misunderstandings

“Clear” or “invisible” braces are one thing

The AAO notes that “clear or invisible braces” can mean clear aligners, ceramic braces or lingual braces. Ceramic braces use tooth-coloured or clear brackets; lingual braces mount brackets on the back sides of the teeth; clear aligners are a different kind of appliance (ADA: removable aligners).

The bracket is not the wire

The bracket is attached to the tooth. The archwire, which fits into the bracket slots, is described by the AAO as the part responsible for moving the teeth.

A bracket is not a band

Both are affixed to teeth and both appear in the same regulation, but they are named as separate devices.

Braces are not always provided by an orthodontist

The ADA states that treatment “may be provided by your dentist or an orthodontist.”

FAQ

What is an orthodontic bracket?

A small attachment affixed to a tooth that holds an archwire in a slot, as part of braces (AAO, ADA, checked 2026-10-30).

What are brackets made of?

The AAO and ADA describe metal (for example stainless steel) and tooth-coloured ceramic or porcelain brackets.

How does FDA regulate orthodontic brackets?

21 CFR 872.5410 names the orthodontic metal bracket as Class I (general controls) and exempt from premarket notification subject to 21 CFR 872.9.

What is a self-ligating bracket?

A bracket with a built-in clip or door that holds the wire, per the AAO. It can be metal or ceramic.

Sources

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