Data / Medical devices / United States / Klowen Braces Dba Klowen Orthodontics
Klowen Braces Dba Klowen Orthodontics: FDA-registered device maker in Richardson, TX, United States, 1 510(k) clearance
Klowen Braces Dba Klowen Orthodontics is registered with the FDA (registration 3030265369) in Richardson, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 21, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030265369
- Address
- 1703 N. Plano Road Ste. 200, Richardson, TX, United States, 75081
- Owner or operator
- KLOwen Braces dba KLOwen Orthodontics (10089784)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- May 7, 2025
- Registered through
- 2026
- Brand names listed
- KLOwen Orthodontic Solution
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bracket, Plastic, Orthodontic | DYW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Indirect Bonding Tray | QJJ | 1 | 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 |
|---|---|---|---|---|---|---|
| April 21, 2025 | K251196 | Composite Orthodontic Brackets and Buttons | DYW | Substantially Equivalent | Ec Certification Service GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 8, 2026 | 99277 | Class II | Ongoing | KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033 | A product error defect may cause incorrect bracket placement. | accessdata.fda.gov |
Compare with other makers
Updated July 8, 2026. 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.