Manufacturer registered with FDA
GSource LLC
Emerson, NJ, United States. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 849 registrations outside the US
- Establishments
- 1United States
Registered in 8 markets
Where regulators' registries name GSource 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 | GSource LLC | 9 device types | — | Below |
| South Korea | MFDS | Manufacturer | gSource,LLCgSource, LLC · GSOURCE · +2 | 21 | 2008–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | GSource LLC | 13 | 2013–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | GSOURCE, LLCGSOURCE LLC | 5 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | gSource, LLC | 5 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GSOURCE, LLC.GSOURCE | 3 | 2012–2018 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GSOURCE | 1 | 2024–2024 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GSOURCE, LLC | 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 GSource 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 |
|---|---|---|---|---|
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | gS | 2019 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | Leksell Stille | 2015 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | Forceps, Rongeur, Surgical | 2010 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | File, Bone, Surgical | 2010 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | Key Elevator | 2015 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | Brun | 2015 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | Chisel, Bone, Surgical | 2010 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | Chisel/Osteotome, Surgical | 2010 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Universal Pliers | 2015 |
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 |
|---|---|---|
| GSOURCE, LLC.FDA reg. 2249529 | EMERSON, NJ, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9038732). 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.