Manufacturer registered with FDA
KLOwen Braces dba KLOwen Orthodontics
Richardson, TX, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What KLOwen Braces dba KLOwen Orthodontics 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 Plastic BracketDYW · Class 2 | Orthodontic brackets | Lister | KLOwen Orthodontic Solution | 2025 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | KLOwen Orthodontic Solution | 2025 |
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
KLOwen Braces dba KLOwen Orthodontics 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: EC Certification Service GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Apr 2025 | K251196 | Composite Orthodontic Brackets and Buttons | EC Certification Service GmbH | DYW Orthodontic Plastic Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| KLOWEN BRACES DBA KLOWEN ORTHODONTICSFDA reg. 3030265369 | Richardson, TX, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089784). 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.