LightForce Orthodontic System
by LightForce Orthodontics 2 variants
510(k) K222764
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK222764 | Date14 Sep 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NJM
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.5470
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The LightForce Orthodontic System is a Ceramic Orthodontic Bracket, designed for use in orthodontic treatment to align teeth through controlled force application. These brackets are part of a patient-specific, 3D-printed orthodontic appliance system, enabling precise and customised tooth movement.
The system is supplied as a reusable, non-sterile medical device intended for dental office use. It is classified as a Class II device under FDA regulations (872.5470) and has received FDA 510K clearance (K222764) as substantially equivalent to predicate devices. Multiple bracket variants are available, identified by unique FEI numbers, and are used in conjunction with orthodontic archwires and ligatures for treatment.
From the manufacturer
LightForce delivers 3D printed patient-specific braces. Generated from a digital orthodontic treatment plan. Made for one. Born from light.
LightForce pioneered generative braces and validated the model with its ceramic bracket system, which has demonstrated up to 60% fewer appointments and 43% shorter treatment times over conventional braces.
offers advanced orthodontic solutions, including customizable braces and a doctor portal for seamless patient management and ordering.
Most dental insurance plans cover braces, including LightForce.1 You can use tax-free dollars from your health savings account (HSA) or flexible spending account (FSA) towards orthodontic treatment. Many doctors offer payment plans—ask your orthodontist what's available.
Other devices from LightForce Orthodontics
Questions
AI-generated answers, 18 Sep 2026
What is the LightForce Orthodontic System used for in clinical practice?
The LightForce Orthodontic System is designed for orthodontic treatment to align teeth through controlled force application. It is part of a patient-specific, 3D-printed appliance system, allowing for precise and customised tooth movement. These ceramic brackets are used in conjunction with orthodontic archwires and ligatures to guide teeth into their desired positions.
Are the LightForce Orthodontic Brackets single-use or reusable, and how should they be handled?
The LightForce Orthodontic System is supplied as a reusable, non-sterile medical device intended for dental office use. Since they are reusable, proper cleaning and sterilisation protocols must be followed between patients to ensure safety and hygiene. The brackets are not sterile out-of-the-box and are not intended for direct patient contact without proper preparation.
What types or sizes of brackets are available in the LightForce Orthodontic System?
The LightForce Orthodontic System includes multiple bracket variants, each identified by unique FEI numbers. These numbers (e.g., 3002336796, 3009048384, etc.) correspond to specific designs tailored for different orthodontic needs. The exact dimensions or variations in size are not specified, but the system is designed to accommodate a range of patient-specific treatments through customisation.
How is the LightForce Orthodontic System regulated, and what does that mean for clinicians?
The LightForce Orthodontic System is classified as a Class II device under FDA regulations and has received FDA 510K clearance (K222764) as substantially equivalent to predicate devices. This means it has undergone review by the FDA’s Dental Advisory Committee (DE) and meets regulatory standards for safety and effectiveness. Clinicians can rely on this clearance as an indication that the device has been evaluated for its intended use in orthodontic treatment.
How should the LightForce Orthodontic System be stored, and are there any special considerations?
The LightForce Orthodontic System is non-sterile and intended for reusable use in a dental office setting. Storage should be in a clean, dry environment to prevent contamination or damage. Since the brackets are part of a customised, 3D-printed system, they should be stored according to manufacturer guidelines to maintain their structural integrity and functionality for repeated use. Avoid exposure to extreme temperatures or moisture.