Manufacturer registered with FDA
Biotem Co., Ltd.
Busan, South Korea. Lists 6 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 48
- 510(k) clearances
- 62017–2023
- Markets registered in
- 81,231 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Biotem 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 | Biotem Co., Ltd. | 6 clearances | 2017–2023 | Below |
| European Union | EUDAMED | Manufacturer | Biotem Co., Ltd. | 1,171 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Biotem Co. Ltd., | 47 | — | Pure Global AI |
| China | NMPA | Registration holder | 佰奥腾有限公司BIOTEM CO., LTD. | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BIOTEM CO., LTD | 3 | 2010–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Biotem Co Ltd | 2 | 2023–2023 | Pure Global AI |
| Egypt | EDA | Manufacturer | BIOTEM CO., LTD, | 1 | 2026–2026 | Pure Global AI |
| Japan | PMDA | Registration holder | Ｂｉｏｔｅｍ Ｃｏ．， Ｌｔｄ． | 1 | 2009–2009 | 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 Biotem 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 | AR_N SLA Type Implant SystemAR_N Type Implant SystemBone Level FixtureBR SLA Type Implant SystemBR Type Implant SystemIR SLA Type Implant SystemIR Type Implant SystemPrimus Implant System | 2018 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | AR_N Type Implant SystemBR SLA Type Implant SystemBR Type Implant SystemIR SLA Type Implant SystemIR Type Implant SystemPrimus Implant System | 2018 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Cortical DrillDrill ExtensionMarking DrillPoint DrillStraight DrillTapered Drill | 2018 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | Fixture PinParallel Pin | 2018 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | AR_N Fixture Driver for MachineAR_N Fixture Driver for WrenchBR Fixture Driver for MachineBR Fixture Driver for WrenchFixture Driver for MachineFixture Driver for WrenchIR Fixture Driver for MachineIR Fixture Driver for Wrench | 2018 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | AR_N Fixture Lab AnalogAR_N Hand DriverAR_N Pick-Up Impression CopingAR_N Solid Lab AnalogAR_N Transfer Impression CopingBR Hand DriverBR Lab AnalogBR Pick-Up Impression CopingBR Transfer Impression CopingFixture Lab Analog 8 moreHand DriverIR Fixture Lab AnalogIR Pick-Up Impression CopingIR Solid Lab AnalogPick-Up Impression CopingSolid Lab AnalogTorque WrenchTransfer Impression Coping | 2018 |
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 Biotem Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Jun 2023 | K222142 | BR SLA Type Implant System | DZE Root-Form Endosseous Implant |
| 14 Jun 2023 | K222144 | IR SLA Type Implant System | DZE Root-Form Endosseous Implant |
| 21 Feb 2020 | K190641 | AR_N SLA Type Implant System | DZE Root-Form Endosseous Implant |
| 9 Feb 2018 | K171179 | BR Type Implant System | DZE Root-Form Endosseous Implant |
| 31 Jan 2018 | K171297 | AR_N Type Implant System | DZE Root-Form Endosseous Implant |
| 1 Dec 2017 | K171185 | IR Type Implant System | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Inosys, Inc. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIOTEM CO., LTD.FDA reg. 3009611645 | Busan, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10057313). 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.