Exceed Tx Orthodontic Bracket

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

Full name

Exceed Tx

510(k) Number

K150702 ↗

FDA Product Code

DYW

Device Class

Class II

Regulation

21 CFR Part 872.5470

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Snore-No-More

  Class II

  FDA 510(k) K922818 Active Cleared 9 Feb 1994

• Oral Safe

  Class I

  FDA 510(k) K840805 Active Cleared 30 Mar 1984

• Variflex

  Class II

  FDA 510(k) K033632 Active Cleared 21 Jan 2004

• Smart Moves Complete

  Class II

  FDA 510(k) K172765 Active Cleared 1 Jun 2018

• Steady Resin

  Class II

  FDA 510(k) K870908 Active Cleared 19 Mar 1987

• Keles Facemask

  Class II

  FDA 510(k) K041718 Active Cleared 15 Oct 2004

See all devices from Great Lakes Orthodontics, Ltd. →

• What is the Exceed Tx Orthodontic Bracket used for?

  The Exceed Tx Orthodontic Bracket is designed specifically for orthodontic treatment to facilitate controlled tooth movement during dental alignment procedures. It attaches to teeth as part of an orthodontic appliance system, ensuring accurate positioning and alignment as part of precision orthodontic therapy.

• Is the Exceed Tx Orthodontic Bracket single-use or reusable?

  The Exceed Tx Orthodontic Bracket is a reusable component within the dental treatment workflow. It must be sterilized between uses to maintain safety and functionality, adhering to standard dental practice protocols for sterilization and infection control.

• How many model variants of the Exceed Tx Orthodontic Bracket exist, and how are they identified?

  The Exceed Tx Orthodontic Bracket comes in multiple model variants, each identified by unique registration numbers such as 3008882689, 3008796797, and others. These variants are part of a broader system designed for dental specialty applications, ensuring compatibility with different orthodontic treatment needs.

• What regulatory pathway does the Exceed Tx Orthodontic Bracket follow?

  The Exceed Tx Orthodontic Bracket is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K150702. It is classified as a Device Class II under regulation 872.5470, indicating it has been determined to be substantially equivalent to a predicate device through the traditional 510(k) review process.

• What storage and handling requirements apply to the Exceed Tx Orthodontic Bracket?

  The Exceed Tx Orthodontic Bracket must be stored and handled according to dental practice protocols to preserve sterility and functionality. Since it is reusable, proper sterilization procedures must be followed between uses to prevent contamination and ensure patient safety.