LightForce Orthodontic System
by LightForce Orthodontics 2 variants
510(k) K232827
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232827 | Date14 Sep 2023 | 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- Withdrawn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. These brackets are part of a patient-specific orthodontic appliance system, utilizing advanced digital planning and manufacturing techniques to provide precise, customised orthodontic solutions.
The system is supplied as a reusable, non-sterile medical device intended for use in dental offices. It is classified under FDA regulation number 872.5470 and has received FDA 510K clearance as substantially equivalent to predicate devices. The brackets are manufactured in multiple reference codes, ensuring compatibility with various orthodontic treatment plans. No MRI safety or sterility requirements are specified.
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.
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 specifically for orthodontic treatment to align teeth. It uses customised, patient-specific digital planning and manufacturing to provide precise, tailored solutions for tooth movement, making it suitable for a range of orthodontic cases where ceramic brackets are preferred.
Are the LightForce Orthodontic Brackets reusable or single-use, and what does that mean for my office?
The LightForce Orthodontic System is supplied as a reusable device, meaning it is intended to be used multiple times in a dental office setting. This design reduces waste and cost per patient, but it requires proper cleaning and sterilisation procedures between uses, as outlined in your office’s infection control protocols.
How many different bracket sizes or models are available, and how do I know which one to order?
The system is available in multiple reference codes (listed under FDA registration numbers), ensuring compatibility with various orthodontic treatment plans. These codes correspond to specific bracket designs or configurations tailored to different clinical needs. Your orthodontic software or manufacturer’s digital planning tools will guide you in selecting the correct reference code based on the patient’s specific case.
Do the LightForce Orthodontic Brackets come sterile, and what storage instructions should I follow?
The LightForce Orthodontic System is explicitly labeled as non-sterile and intended for reuse in dental offices. Since it is reusable, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow your office’s standard protocols for handling reusable medical devices to maintain sterility between uses.
What regulatory pathway was followed for FDA clearance of the LightForce Orthodontic System, and what does that mean for me?
The LightForce Orthodontic System received FDA 510K clearance through a traditional review process, determined to be *substantially equivalent* to predicate devices. This means the FDA evaluated it against existing orthodontic brackets and concluded it meets the same performance standards. For you, this indicates the device has undergone FDA scrutiny for safety and effectiveness, but always follow your office’s protocols and the manufacturer’s instructions for use.