Manufacturer registered with FDA
AD Systems And Consulting (Pty) Ltd.
Pretoria, South Africa. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1South Africa
Registered in 2 markets
Where regulators' registries name AD Systems And Consulting (Pty) Ltd. 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 | AD Systems And Consulting (Pty) Ltd. | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | AD Systems and Consulting (PTY) Ltd. | 1 | 2020–2020 | 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 AD Systems And Consulting (Pty) Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Denture Base Resi n DT20 | 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
AD Systems And Consulting (Pty) Ltd. 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: Hangzhou SHINING3D Dental Technology Co., Ltd (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Mar 2025 | K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AD SYSTEMS AND CONSULTINGFDA reg. 3015532223 | Silver Lakes, Pretoria Gauteng, South Africa | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060805). 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.