LightForce Orthodontic System
510(k) K200148
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200148 | Date21 Feb 2020 | 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- Withdrawn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
- Full name
- LightForce Orthodontic System (LFO System)
- 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 precision-engineered to apply controlled forces for gradual tooth movement, aiding in the correction of dental alignment issues.
The system is supplied as a reusable, non-sterile medical device intended for dental office use. It is classified under FDA regulation 872.5470 and has received FDA 510K clearance under the Traditional pathway. Brackets are available in multiple reference codes (e.g., 3009048384, 1815540) and are intended for single-patient application per treatment plan.
From the manufacturer
LightForce delivers 3D printed patient-specific braces. Generated from a digital orthodontic treatment plan. Made for one. Born from light.
LightForce Orthodontics Adds Metal Option to Its Generative Braces System BOSTON - April 28, 2026 - LightForce Orthodontics, the company behind the world's first fully individualized 3D-printed bracket, today announced LightBracket Metal™ — the first-of-its-kind patient-specific 3D-printed metal bracket.
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.