Data / Medical devices / Israel / Nova Implants Ltd
Nova Implants Ltd: FDA-registered device maker in Or-Yehuda Tel Aviv, Israel, 1 510(k) clearance
Nova Implants Ltd is registered with the FDA (registration 3011808221) in Or-Yehuda Tel Aviv, Israel. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 29, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011808221
- Address
- 5 Yoni Netanyahu street, Or-Yehuda Tel Aviv, Israel, 6037603
- Owner or operator
- Nova Implants (10049664)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 7, 2015
- Registered through
- 2026
- Brand names listed
- ANG Anatomic Angulated Abutment, ANTAnatomic Angulated Curve, ASM Angulated Abutment, Analog, BAT Ball Attachment, Conical Drills with External Irrigation, Countersink, Dental Drill and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Specification developer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Specification developer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 29, 2015 | K150363 | NOVA Dental Implants System | DZE | Substantially Equivalent | Nova Implants , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Bur, Dental
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Drill, Dental, Intraoral
Updated June 29, 2015. 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.