Manufacturer registered with FDA
REX Implants, Inc
Columbus, OH, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 3
- 510(k) clearances
- 12022–2022
- Markets registered in
- 310 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name REX Implants, 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 | Manufacturer | REX Implants, Inc | 1 clearances | 2022–2022 | Below |
| Australia | TGA | Manufacturer | Rex Implants Inc | 9 | 2022–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | Rex Implants, Inc | 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 REX Implants, 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | — | 2020 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | PiezoImplant System | 2022 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | PiezoImplant System | 2022 |
| Blade-Form Endosseous Dental ImplantNRQ · Class 2 | — | Maker | PiezoImplant System | 2022 |
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 |
|---|---|---|
| REX IMPLANTS, INCFDA reg. 3014174860 | Columbus, OH, United States | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056452). 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.