Manufacturer registered with FDA
ARDS Industries
Petah Tikva, Israel. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 413 registrations outside the US
- Establishments
- 1Israel
Registered in 4 markets
Where regulators' registries name ARDS Industries 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 | ARDS Industries | 3 device types | — | Below |
| Australia | TGA | Manufacturer | ARDS Industries Ltd | 7 | 2021–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ARDS Industries Ltd.ARDS INDUSTRIES LTD. | 5 | 2012–2021 | Pure Global AI |
| Israel | AMAR | Manufacturer | ARDS INDUSTRIES LTD | 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 ARDS Industries currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | ARDS Dental Implant | 2008 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | ARDS dental implant accessories | 2022 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | ARDS Dental Implant | 2008 |
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
ARDS Industries 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: Ards, Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 5 Sep 2008 | K071803 | ARDS DENTAL IMPLANTS | Ards, Ltd. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ARDS Industries LtdFDA reg. 3007529467 | Petah Tikva Central, Israel | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028117). 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.