Manufacturer registered with FDA
Oneday Biotech Co., Ltd.
DAEGU, South Korea. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 38
- 510(k) clearances
- 22023–2024
- Markets registered in
- 514 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Oneday Biotech 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 | Oneday Biotech Co., Ltd. | 2 clearances | 2023–2024 | Below |
| China | NMPA | Registration holder | 一日生技有限公司Oneday Biotech Co., Ltd. | 4 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Oneday Biotech Co., Ltd. | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | ONEDAY BIOTECH CO., LTD. | 3 | 2024–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Oneday Biotech Co., Ltd.Oneday Biotech., Ltd. | 3 | 2020–2024 | 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 Oneday Biotech 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | I DO IMPLAMTOneday Biotech ImplantOneday Mini Implant System | 2020 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Oneday Implant AbutmentOneday Mini Implant System | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Bone ExpanderComplete Kit (KIT001, KIT002)Depth PinDigital Lab AnalogDigital Multi Unit AnalogDrill ExtensionDrill StopperDriver ConnectorIntraoral Scan BodyLab Analog 23 moreLindemann DrillMount Driver (Machine)Mount Driver (Ratchet)Multi unit Lab analogOne Drill KIT [ODK]One Drill Plus KIT [ODPK]Oneday Guide KIT [OGK]Oneday Guide Sinus KIT [OGSK]Pararlle PinProfile DrillScan BodyScrew Driver (Machine)Screw Driver (Ratchet)SCS Driver for RatchetTaper Drill-1Taper Drill-2Ti-BaseTorque WrenchTwist DrillUnigrip Driver for RatchetUniversal Prosthetic Kit (IPDK)1.2 Hex Driver for Ratchet1.25 Hex Driver for Ratchet | 2022 |
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
Oneday Biotech Co., Ltd. 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: I DO Biotech Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Jul 2020 | K192294 | I Do | I DO Biotech Co., Ltd. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Oneday Biotech Co., Ltd.FDA reg. 3017548645 | DAEGU, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10078125). 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.