Manufacturer registered with FDA
Plasti-med Plastik Medikal Urunler San. ve Tic. Ltd. Sti.
Tuzla, Türkiye. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 71,709 registrations outside the US
- Establishments
- 1Türkiye
Registered in 7 markets
Where regulators' registries name Plasti-med Plastik Medikal Urunler San. ve Tic. Ltd. Sti. 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 | Plasti-med Plastik Medikal Urunler San. ve Tic. Ltd. Sti. | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti. | 1,590 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Plasti-med Plastik Medikal Urunler San.ve Tic. Ltd.Sti. | 95 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | PLASTI-MED PLASTIK MEDIKAL URUNLER SAN. VE TIC .LTD. STIPLASTI-MED PLASTIK MEDIKAL ÜRÜNLER SAN.VE TIC.LTD.STI | 19 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | PLASTİ-MED Plastik Medikal Ürünler San. Ve Tic. Ltd. Şti. | 2 | 2025–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | PLASTI-MED PLASTIK MEDIKAL ÜRÜNLER SAN. VE TIC. LTD. STI.PLASTI-MED® PLASTIK MEDIKAL URUNLER SAN. VE TIC. LTD. STI. | 2 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | PLASTI-MED PLASTIK MEDIKAL URUNLER SAN. VE TIC. LTD. STI. | 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 Plasti-med Plastik Medikal Urunler San. ve Tic. Ltd. Sti. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | DISPOSABLE ORAL SWAB - STERILE - 490 101DISPOSABLE ORAL SWAB NONSTERILE - 490 102SPONGE SWAB - 490 104 | 2021 |
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 |
|---|---|---|
| PLASTI-MED PLASTIK MEDIKAL URUNLER SAN. VE TIC. LTD. STI.FDA reg. 3018762668 | Tuzla Istanbul, Türkiye | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10080023). 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.