Registered with FDA
Orthone INC.
Wilmington, DE, United States. Lists 14 dental device types with FDA across 1 registered establishment.
- Device types listed
- 14
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Orthone INC. 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 | Orthone INC. | 14 device types | — | Below |
| Philippines | FDA Philippines | Registration holder | Orthone, Inc. | 2 | 2023–2023 | 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 Orthone INC. 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 Material BandDYO · Class 1 | Orthodontic wires & bands | Lister | orthone | 2024 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | orthone | 2024 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Lister | orthone | 2024 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | orthone | 2024 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | orthone | 2024 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Lister | orthone | 2024 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Lister | orthone, Orthodontic Forceps | 2025 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | orthone, Orthodontic wax, Orthodontic Wax | 2024 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | orthone | 2024 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Lister | orthone, Forceps, Dental Tweezers | 2024 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | orthone | 2024 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | orthone, Toothpaste | 2025 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | orthone | 2024 |
| Indirect Bonding TrayQJJ · Class 1 | — | Lister | orthone, Orthodontic Indirect Bonding Tray, OBRACE GUIDE | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ORTHONE INC.FDA reg. 3034278341 | Wilmington, DE, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092184). 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.