Orthodontic Ceramic Brackets

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K042178 ↗

FDA Product Code

NJM

Device Class

Class II

Regulation

21 CFR Part 872.5470

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• What are orthodontic ceramic brackets used for?

  Orthodontic ceramic brackets are dental devices used to support archwires in the alignment and positioning of teeth during orthodontic therapy. They are made of ceramic material and attached to teeth to facilitate proper tooth movement.

• Are these brackets single-use or reusable?

  The device is supplied as either a single-use or reusable product depending on the specific model selected. The manufacturer offers various models with different usage specifications to meet clinical needs.

• What sizes and models are available for these ceramic brackets?

  The orthodontic ceramic brackets are available in various sizes and models as specified by the manufacturer. This variety allows clinicians to select the appropriate bracket for different teeth and treatment requirements.

• What is the regulatory status of these orthodontic brackets?

  These orthodontic ceramic brackets have received FDA 510(k) clearance with product code NJM and are classified under Class II - Special Controls. This indicates they meet specific safety and effectiveness requirements for dental use.