Manufacturer registered with FDA
Nobio Ltd.
Kadima, Israel. Lists 2 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 52019–2020
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Nobio Ltd. 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 | Nobio Ltd. | 5 clearances | 2019–2020 | Below |
| Israel | AMAR | Manufacturer | NOBIO LTDNobio LTD | 1 | — | 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 Nobio Ltd. 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 | Infinix Bulk Fill Flow CompositeInfinix Flowable CompositeInfinix Universal Composite | 2020 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Infinix Universal bond | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Nobio Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Aug 2020 | K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite | EBF Resin Tooth Shade Material |
| 24 Sep 2019 | K183391 | Novidia Universal Bond | KLE Resin Tooth Bonding Agent |
| 13 Sep 2019 | K182921 | Infinix Universal Composite | EBF Resin Tooth Shade Material |
| 12 Jul 2019 | K182714 | Novidia Bulk Fill Flow Composite | EBF Resin Tooth Shade Material |
| 3 Jul 2019 | K182580 | Novidia Flowable Composite | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NOBIO LTD.FDA reg. 3015189878 | Kadima Central, Israel | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10079375). 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.