Manufacturer registered with FDA
Tangent Technologies LLC
Franklin, IN, United States. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Tangent Technologies LLC 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 | Tangent Technologies LLC | 10 device types | — | Below |
| South Korea | MFDS | Manufacturer | Tangent Orthodontics | 1 | 2026–2026 | 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 Tangent Technologies LLC 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 WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Wire and Archwires-Beta Titanium (Beta Ti); Nickel Titanium (NiTi) ; Stainless Steel (SS) ; Nickel Cobalt | 2019 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Lister | Orthodontic Buccal Tubes and Orthodontic Metal Tubes | 2024 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Elastic Separators; Elastic Thread; Elastics; Energy Chain; Elastomeric Ligatures; Rotation Wedge | 2020 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Lister | Orthodontic Bands | 2024 |
| Orthodontic Wire ClampECN · Class 1 | — | Lister | Bondable Button: Eruption Appliance, Crimpable Stop, Crimpable Hook, | 2024 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Springs- Nickel Titanium (NiTi) ; Stainless Steel (SS) : Nickel Cobalt | 2024 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | Patient Relief Wax | 2024 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Impression Tray | 2024 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | Orthodontic Metal Brackets | 2024 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Lister | Ceramic Orthodontic Brackets | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Tangent Technologies LLC 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: GNI Co., LTD (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Nov 2019 | K182672 | ROSA Bracket | GNI Co., LTD | NJM Orthodontic Ceramic Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TANGENT ORTHODONTICSFDA reg. 3015259864 | Franklin, IN, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
Other names on FDA records
Tangent Orthodontics
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059559). 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.