Manufacturer registered with FDA
ALLONUS Tech Co., Ltd.
Yangsan-Si, South Korea. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 14
- 510(k) clearances
- 12024–2024
- Markets registered in
- 1United States
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Devices listed with FDA
What ALLONUS Tech 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | ASC Screw DriverDigital AnalogGM Screw DriverLab AnalogLab Screw DriverScan BodyScan Body KitScrew DriverSCS Screw DriverTorque Ratchet Wrench 3 moreUnigrip Screw Driver1.2 Hex Screw Driver1.27 Hex Screw Driver | 2025 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | ALLONUS Tech Prosthetics | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names ALLONUS Tech Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 Dec 2024 | K241616 | ALLONUS Tech Prosthetics | NHA Endosseous Dental Implant Abutment |
Some of these clearances are listed with FDA today by another company: Imagine Milling Technologies, LLC (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ALLONUS TECH CO., LTD.FDA reg. 3035532393 | Yangsan-si Gyeongnam, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092694). 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.