Data / Medical devices / United States / LightForce Orthodontics
LightForce Orthodontics: FDA-registered device maker in Wilmington, MA, United States, 5 510(k) clearances
LightForce Orthodontics is registered with the FDA (registration 3027460334) in Wilmington, MA, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 14, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027460334
- Address
- 400 Research Dr., Ste 125, Wilmington, MA, United States, 01887
- Owner or operator
- LightForce Orthodontics, Inc (10059693)
- Roles
- Manufacturer
- First device listed
- February 12, 2019
- Registered through
- 2026
- Brand names listed
- LightBracket, LightForce Orthodontic System, Signature Orthodontics
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bracket, Ceramic, Orthodontic | NJM | 2 | Manufacturer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Manufacturer | accessdata.fda.gov |
| Orthodontic Software | PNN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 14, 2023 | K232827 | LightForce Orthodontic System | NJM | Substantially Equivalent | Lightforce Orthodontics | accessdata.fda.gov |
| September 14, 2022 | K222764 | LightForce Orthodontic System | NJM | Substantially Equivalent | Lightforce Orthodontics | accessdata.fda.gov |
| February 21, 2020 | K200148 | LightForce Orthodontic System (LFO System) | NJM | Substantially Equivalent | Lightforce Orthodontics | accessdata.fda.gov |
| January 2, 2019 | K183542 | Signature Orthodontic System | NJM | Substantially Equivalent | Signature Orthodontics | accessdata.fda.gov |
| June 13, 2018 | K181271 | Signature Orthodontic System | NJM | Substantially Equivalent | Signature Orthodontics | accessdata.fda.gov |
Compare with other makers
- All makers of Bracket, Ceramic, Orthodontic
- All makers of Orthodontic Software
- All makers of Bracket, Metal, Orthodontic
Updated September 14, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.