Data / Medical devices / Israel / Uniqa Dental Ltd
Uniqa Dental Ltd: FDA-registered device maker in Netanya Central, Israel, 1 510(k) clearance
Uniqa Dental Ltd is registered with the FDA (registration 3014938434) in Netanya Central, Israel. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 8, 2018. 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
- 3014938434
- Address
- 2 Ha-Tsoran street Entrance A, 2nd Floor, Netanya Central, Israel, 4250602
- Owner or operator
- UNIQA DENTAL LTD (10058710)
- Roles
- Manufacturer
- First device listed
- October 23, 2018
- Registered through
- 2026
- Brand names listed
- 15 angled abutment/15 abutment H- Internal Hex RP, 15 angled anatomic abutment/15 abutment with shoulder, 17 angled Multi Unit Abutment, MUA, D-type/17 multi unit abutment D-type GH- Internal Hex RP, 25 angled abutment/25 abutment H- Internal Hex RP, 25 angled anatomic abutment/25 abutment with shoulder, 30 angled Multi Unit Abutment, MUA, D-type/30 multi unit abutment D-type GH- Internal Hex RP, Ball attachment abutment, Bite index and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 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 |
|---|---|---|---|---|---|---|
| August 8, 2018 | K180598 | UNIQA Dental Implants System | DZE | Substantially Equivalent | Uniqa Dental, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Drill, Dental, Intraoral
- All makers of Accessories, Implant, Dental, Endosseous
Updated August 8, 2018. 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.