Manufacturer registered with FDA
PNUAdd Co., Ltd.
Busan, South Korea. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 13
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1South Korea
Registered in 2 markets
Where regulators' registries name PNUAdd Co., 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 | PNUAdd Co., Ltd. | 3 device types | — | Below |
| Taiwan | TFDA | Manufacturer | PNUADD Co., Ltd | 1 | 2025–2025 | 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 PNUAdd Co., 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 Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | JB Fork Radi+, RAYeTrayJB Tray, JB Tray Radi+ | 2023 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | ADD POP BOW | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | PNUADD Standard Surgical KIT_Depth Gaouge, Torque WrenchPNUADD Standard Surgical KIT_Lance Drill, Stright Stopper Drill, Final Stopper Drill;PNUADD Standard Surgical KIT_Parallel Pin, Fixture Driver, Hex Driver, Drill Stopper;PNUADD Taper Surgical KIT_ Fixture Driver, Depth Gauge, Torque Ratchet;PNUADD Taper Surgical KIT_ Lance Drill, Lindemann Drill, Drill Extension, Straight Drill, Taper Surgical Drill;PNUADD Taper Surgical KIT_ Taper Cortical Drill, Parallel Pin, Hand Driver, Ratchet Driver, No Mount Driver;PNUADD TGK KIT_Drill Guide, Vertical Anchor Screw, Lateral Anchor Screw, Guide Point Drill;PNUADD TGK KIT_Guide Initial Drill, Guide Step Drill, Guide Taper Drill, Guide Tissue Punch;PNUADD TGK KIT_Lateral Anchor Drill, Guide Fixture Driver, Mount Driver, Hand Driver;PNUADD TGK KIT_Lateral Anchor Driver, One Direction Torque Wrench | 2025 |
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 |
|---|---|---|
| PNUAdd Co., Ltd.FDA reg. 3029973772 | Busan, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089089). 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.