Manufacturer registered with FDA
PIC dental LLC
Miami, FL, United States. Lists 3 dental device types with FDA across 2 registered establishments.
- Device types listed
- 3
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 2Spain, United States
Registered in 2 markets
Where regulators' registries name PIC dental LLC 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 | PIC dental LLC | 3 device types | — | Below |
| Taiwan | TFDA | Manufacturer | IDITEC NORTH WEST, S.L. | 1 | 2026–2026 | 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 PIC dental LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Color ScannerKZN · Class 2 | — | Maker | PIC camera | 2022 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | PIC transfer | 2022 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | PIC systemPIC system gravityPIC system station | 2022 |
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 |
|---|---|---|
| IDITEC NORTH WEST S.L.FDA reg. 3015914458 | TORRELODONES Madrid(Autonomous Community), Spain | Manufacturer |
| PIC DENTAL LLCFDA reg. 3015915424 | Miami, FL, United States | Repacker / relabeler |
Other names on FDA records
Iditec North West, S.L.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10079630). 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.