Manufacturer registered with FDA
Istar dental lab
Shenzhen, China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 24 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Istar dental lab 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 | Istar dental lab | 4 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Istar dental lab | 4 | — | 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 Istar dental lab currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | Clear Aligner: Essix and TPU | 2025 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Maker | Porcelain Fused To Metal Crown/Bridge; Zirconia Crown/Bridge; Emax Crown/Bridge: Anterior and Posterior | 2025 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Acrylic denture: ACD-upper and lower; PRD-upper and lower | 2025 |
| Preformed CrownELZ · Class 1 | — | Maker | Porcelain Fused To Metal Crown/Bridge; Zirconia Crown/Bridge; Emax Crown/Bridge: Anterior and Posterior | 2025 |
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 |
|---|---|---|
| ISTAR DENTAL LABFDA reg. 3039441248 | Shenzhen Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093740). 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.