Manufacturer registered with FDA
North Bel Intl. S.r.l.
Northbrook, IL, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 39 registrations outside the US
- Establishments
- 1Italy
Registered in 3 markets
Where regulators' registries name North Bel Intl. S.r.l. 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 | North Bel Intl. S.r.l. | 2 device types | — | Below |
| Colombia | INVIMA | Manufacturer | NORTH BEL INTL. SRL.NORTH BEL INT'L SRL. | 6 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | NORTH BEL INTL. SRL. | 3 | — | 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 North Bel Intl. S.r.l. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | — | 1997 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | — | 1997 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NORTH BEL INTL. SRL.FDA reg. 8021041 | PADERNO DUGNANO Milano, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8021041). 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.