Registered with FDA
Orthodentalusa Corp.
Weston, FL, United States. Lists 16 dental device types with FDA across 1 registered establishment.
- Device types listed
- 16
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Orthodentalusa Corp. 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 | Orthodentalusa Corp. | 16 device types | — | Below |
| Israel | AMAR | Manufacturer | ORTHODENTALUSA CORP. | 1 | — | 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 Orthodentalusa Corp. currently lists, by FDA device type, with the brand and model names on the listing.
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
Orthodentalusa Corp. 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: Xianyang North West Medical Instrument (Group) Co. (1), American Green Dent. Mfg, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 26 Jul 2013 | K130410 | DENTAL UNIT WITH CHAIR | Xianyang North West Medical Instrument (Group) Co. | EIA Operative Dental Unit |
| 21 Dec 2004 | K033044 | DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER | American Green Dent. Mfg, Inc. | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ORTHODENTALUSA CORP.FDA reg. 3007962015 | Weston, FL, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10031414). 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.