Manufacturer registered with FDA
3BFAB Teknoloji Anonim Sirketi
ISTANBUL, Türkiye. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 28 registrations outside the US
- Establishments
- 1Türkiye
Registered in 2 markets
Where regulators' registries name 3BFAB Teknoloji Anonim Sirketi 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 | 3BFAB Teknoloji Anonim Sirketi | 5 device types | — | Below |
| European Union | EUDAMED | Manufacturer | 3BFAB TEKNOLOJI ANONIM ŞIRKETI | 8 | — | 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 3BFAB Teknoloji Anonim Sirketi currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Dentafab NanoCeram | 2026 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Dentafab Tray ResinDentafab Visione ResinPowerresins Mock Up Resin | 2024 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Dentafab NanoCeram | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dentafab SGPowerresins SG | 2022 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | Dentafab NanoCeram | 2026 |
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
3BFAB Teknoloji Anonim Sirketi 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: 3BFAB Teknoloji AS (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Jul 2026 | K262681 | NanoCeram Resin | 3BFAB Teknoloji AS | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| 3BFAB TEKNOLOJI ANONIM SIRKETIFDA reg. 3020702076 | ISTANBUL, Türkiye | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083750). 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.