Registered with FDA
Orthoworld, L.L.C.
Red Oak, TX, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 61
- 510(k) clearances
- 0as applicant
- Markets registered in
- 48 registrations outside the US
- Establishments
- 1United States
Registered in 4 markets
Where regulators' registries name Orthoworld, L.L.C. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Orthoworld, L.L.C. | 3 device types | — | Below |
| Australia | TGA | Manufacturer | Orthoworld | 3 | 2014–2014 | Pure Global AI |
| Canada | Health Canada | Registration holder | ORTHOWORLD, L.L.C. | 3 | 2014–2014 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Orthoworld LLC | 2 | — | 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 Orthoworld, L.L.C. 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 | Lister | Fastbraces® Aesthetic ArchwiresFastbraces® Classic Metal ArchwiresFastbraces® Combo ArchwiresFastbraces® Combo-Turbo ArchwiresFastbraces® Ligature Wires (Clear, 3-pack)Fastbraces® Ligature Wires (Metal, 3-pack)Fastbraces® RetainerFastbraces® Turbo® ArchwiresFastbraces® Turbo® Xtra Archwires | 2011 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | FASTBRACES® CLASSIC Metal LL/LR 1/2FASTBRACES® CLASSIC Metal LL/UR 6FASTBRACES® CLASSIC Metal LL3FASTBRACES® CLASSIC Metal LR3FASTBRACES® CLASSIC Metal U/L 4/5FASTBRACES® CLASSIC Metal UL/LR 6FASTBRACES® CLASSIC Metal UL1FASTBRACES® CLASSIC Metal UL2FASTBRACES® CLASSIC Metal UL3FASTBRACES® CLASSIC Metal UR1 29 moreFASTBRACES® CLASSIC Metal UR2FASTBRACES® CLASSIC Metal UR3Fastbraces® Metal Bracket KitFastbraces® Turbo® Bracket KitFASTBRACES® TURBO® LL/LR 1/2FASTBRACES® TURBO® LL/UR 6FASTBRACES® TURBO® LL3FASTBRACES® TURBO® LR3FASTBRACES® TURBO® U/L 4/5FASTBRACES® TURBO® UL/LR 6FASTBRACES® TURBO® UL1FASTBRACES® TURBO® UL2FASTBRACES® TURBO® UL3FASTBRACES® TURBO® UR1FASTBRACES® TURBO® UR2FASTBRACES® TURBO® UR3Fastbraces® Turbo® XTRA Bracket KitFASTBRACES® TURBO® XTRA LL/LR 1/2FASTBRACES® TURBO® XTRA LL/UR 6FASTBRACES® TURBO® XTRA LL3FASTBRACES® TURBO® XTRA LR3FASTBRACES® TURBO® XTRA U/L 4/5FASTBRACES® TURBO® XTRA UL/LR 6FASTBRACES® TURBO® XTRA UL1FASTBRACES® TURBO® XTRA UL2FASTBRACES® TURBO® XTRA UL3FASTBRACES® TURBO® XTRA UR1FASTBRACES® TURBO® XTRA UR2FASTBRACES® TURBO® XTRA UR3 | 2011 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Lister | FASTBRACES® CLASSIC CLEAR LL/LR 1/2FASTBRACES® CLASSIC CLEAR LL3FASTBRACES® CLASSIC CLEAR LR3FASTBRACES® CLASSIC CLEAR U/L 4/5FASTBRACES® CLASSIC CLEAR UL1FASTBRACES® CLASSIC CLEAR UL2FASTBRACES® CLASSIC CLEAR UL3FASTBRACES® CLASSIC CLEAR UR1FASTBRACES® CLASSIC CLEAR UR2FASTBRACES® CLASSIC CLEAR UR3 3 moreFastbraces® Clear Bracket KitFastbraces® Combo Bracket KitFastbraces® Combo-Turbo Bracket Kit | 2014 |
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
Orthoworld, L.L.C. 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: Orthodontic Design and Production, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 7 Jun 2013 | K130446 | FASTBRACES CERAMIC BRACKETS | Orthodontic Design and Production, Inc. | NJM Orthodontic Ceramic Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ORTHOWORLD, L.L.C.FDA reg. 3009402818 | Red Oak, TX, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10038866). 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.