Data / Medical devices / Turkey / 3bfab Teknoloji Anonim Sirketi
3bfab Teknoloji Anonim Sirketi: FDA-registered device maker in Istanbul, Turkey, 1 510(k) clearance
3bfab Teknoloji Anonim Sirketi is registered with the FDA (registration 3020702076) in Istanbul, Turkey. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 31, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3020702076
- Address
- Dudullu OSB Mah. IMES-501 sok. E Blok No:9 Umraniye, Istanbul, Turkey, 34775
- Owner or operator
- 3BFAB TEKNOLOJI ANONIM SIRKETI (10083750)
- Roles
- Manufacturer
- First device listed
- August 24, 2022
- Registered through
- 2026
- Brand names listed
- Dentafab Guard Resin, Dentafab NanoCeram, Dentafab SG, Dentafab Tray Resin, Dentafab Visione Resin, PowerResins Guard Resin, Powerresins Mock Up Resin, Powerresins SG
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2026 | K262681 | NanoCeram Resin | EBI | Substantially Equivalent | 3BFAB TEKNOLOJI A.S. | accessdata.fda.gov |
Compare with other makers
- All makers of Protector, Dental
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Material, Tooth Shade, Resin
- All makers of Additively Manufactured, Preformed, Resin Denture Tooth
- All makers of Material, Impression Tray, Resin
- All makers of Accessories, Implant, Dental, Endosseous
Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.