Data / Medical devices / Israel / Nobio Ltd.
Nobio Ltd.: FDA-registered device maker in Kadima Central, Israel, 2 510(k) clearances
Nobio Ltd. is registered with the FDA (registration 3015189878) in Kadima Central, Israel. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 14, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015189878
- Address
- 8 Hamatechet St., Kadima Central, Israel, 6092000
- Owner or operator
- Nobio Ltd. (10079375)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 3, 2020
- Registered through
- 2026
- Brand names listed
- Infinix Bulk Fill Flow Composite, Infinix Flowable Composite, Infinix Universal Composite, Infinix Universal bond
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Complaint file establishment, 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 14, 2020 | K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite | EBF | Substantially Equivalent | Nobio , Ltd. | accessdata.fda.gov |
| September 24, 2019 | K183391 | Novidia Universal Bond | KLE | Substantially Equivalent | Nobio , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 14, 2020. 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.