Data / Medical devices / United States / Orthoworld, L.L.C.
Orthoworld, L.L.C.: FDA-registered device maker in Red Oak, TX, United States, 1 510(k) clearance
Orthoworld, L.L.C. is registered with the FDA (registration 3009402818) in Red Oak, TX, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 7, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009402818
- Address
- 2670 FM 983, Red Oak, TX, United States, 75154
- Owner or operator
- Orthoworld, L.L.C. (10038866)
- Roles
- Repackager or relabeler
- First device listed
- November 17, 2011
- Registered through
- 2026
- Brand names listed
- FASTBRACES® CLASSIC CLEAR LL/LR 1/2, FASTBRACES® CLASSIC CLEAR LL3, FASTBRACES® CLASSIC CLEAR LR3, FASTBRACES® CLASSIC CLEAR U/L 4/5, FASTBRACES® CLASSIC CLEAR UL1, FASTBRACES® CLASSIC CLEAR UL2, FASTBRACES® CLASSIC CLEAR UL3, FASTBRACES® CLASSIC CLEAR UR1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bracket, Ceramic, Orthodontic | NJM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 7, 2013 | K130446 | FASTBRACES CERAMIC BRACKETS | NJM | Substantially Equivalent | Orthodontic Design and Production, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Orthodontic
- All makers of Bracket, Ceramic, Orthodontic
- All makers of Bracket, Metal, Orthodontic
Updated June 7, 2013. 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.