Manufacturer registered with FDA
LightForce Orthodontics, Inc
Wilmington, MA, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 4
- 510(k) clearances
- 32020–2023
- Markets registered in
- 44 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name LightForce Orthodontics, Inc as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | LightForce Orthodontics, Inc | 3 clearances | 2020–2023 | Below |
| Canada | Health Canada | Registration holder | LIGHTFORCE ORTHODONTICS, INC. | 2 | 2020–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | LightForce Orthodontics Inc | 1 | 2022–2022 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | LightForce Orthodontics | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What LightForce Orthodontics, Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | LightForce Orthodontic SystemSignature Orthodontics | 2019 |
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | LightForce Orthodontic System | 2022 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | LightBracket | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names LightForce Orthodontics, Inc as the applicant.
Also lists devices cleared under other names
LightForce Orthodontics, Inc lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Signature Orthodontics (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Jan 2019 | K183542 | Signature Orthodontic System | Signature Orthodontics | NJM Orthodontic Ceramic Bracket |
| 13 Jun 2018 | K181271 | Signature Orthodontic System | Signature Orthodontics | NJM Orthodontic Ceramic Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| LightForce OrthodonticsFDA reg. 3027460334 | Wilmington, MA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059693). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.