Manufacturer registered with FDA
Park Istre LLC
Dallas, TX, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 49 registrations outside the US
- Establishments
- 1United States
Registered in 4 markets
Where regulators' registries name Park Istre LLC 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 | Park Istre LLC | 1 device types | — | Below |
| Canada | Health Canada | Registration holder | PARK ISTRE LLC | 7 | 2019–2023 | Pure Global AI |
| Australia | TGA | Manufacturer | Park Istre LLC | 1 | 2023–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | PARK-ISTRE, LLC. | 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 Park Istre LLC 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 CrownELZ · Class 1 | — | Maker | Acero 3S CrownsAcero ES CrownsAcero ESL CrownsAcero Narrow NA CrownsAcero NSAcero XT CrownsAcero Z1 Crowns | 2006 |
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 |
|---|---|---|
| PARK-ISTRE, LLC.FDA reg. 3006007013 | DALLAS, TX, United States | Complaint file establishment, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9093900). 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.