Manufacturer registered with FDA
Orthopli Corp.
Philadelphia, PA, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 5760 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name Orthopli 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 | Manufacturer | Orthopli Corp. | 4 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | ORTHOPLI CORPORATION | 754 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ORTHOPLI CORPORATIONORTHO-PLI CORPORATION | 3 | 2009–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | ORTHOPLI CORP.Orthopli Corp. | 2 | 2003–2010 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ORTHOPLI CORPORATION | 1 | 2019–2019 | 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 Orthopli Corp. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | — | 2000 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Orthopli Corporation | 2019 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | — | 2001 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | VARIOUS ORTHODONTIC PLIERS | 2000 |
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 |
|---|---|---|
| ORTHOPLI CORP.FDA reg. 2518634 | PHILADELPHIA, PA, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2518634). 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.