Manufacturer registered with FDA
Pierrel S.p.A.
Capua, Italy. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 35 registrations outside the US
- Establishments
- 1Italy
Registered in 3 markets
Where regulators' registries name Pierrel S.p.A. 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 | Pierrel S.p.A. | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Pierrel S.p.A. | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PIERREL S.P.A.Pierrel S.p.A. | 2 | 1977–2010 | 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 Pierrel S.p.A. 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 NeedleDZM · Class 1 | Dental needles & syringes | Maker | Orabloc thirtyESOrabloc thirtySOrabloc twenty5LOrabloc twenty7LOrabloc twenty7S | 2021 |
| Soft Tissue Detector Diagnostic LightNXV · Class 2 | — | Maker | G.o.c.c.l.e.s.G.o.c.c.l.e.s. light | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Pierrel S.p.A. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Pierrel Pharma S.R.L. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Sep 2015 | K151630 | G.o.c.c.l.e.s. | Pierrel Pharma S.R.L. | NXV Soft Tissue Detector Diagnostic Light |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PIERREL S.P.A.FDA reg. 3006999064 | Capua Caserta, Italy | Private-label distributor, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10050470). 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.