Data / Medical devices / South Korea / Biotem Co., Ltd.
Biotem Co., Ltd.: FDA-registered device maker in Busan, South Korea, 6 510(k) clearances
Biotem Co., Ltd. is registered with the FDA (registration 3009611645) in Busan, South Korea. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 24, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009611645
- Address
- # 422, Sasang-ro, Sasang-gu, Busan, South Korea, 46925
- Owner or operator
- Biotem Co., Ltd. (10057313)
- Roles
- Manufacturer
- First device listed
- March 19, 2018
- Registered through
- 2026
- Brand names listed
- AR_N Fixture Driver for Machine, AR_N Fixture Driver for Wrench, AR_N Fixture Lab Analog, AR_N Hand Driver, AR_N Pick-Up Impression Coping, AR_N SLA Type Implant System, AR_N Solid Lab Analog, AR_N Transfer Impression Coping and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 24, 2023 | K222142 | BR SLA Type Implant System | DZE | Substantially Equivalent | Biotem Co., Ltd. | accessdata.fda.gov |
| June 14, 2023 | K222144 | IR SLA Type Implant System | DZE | Substantially Equivalent | Biotem Co., Ltd. | accessdata.fda.gov |
| February 21, 2020 | K190641 | AR_N SLA Type Implant System | DZE | Substantially Equivalent | Biotem Co., Ltd. | accessdata.fda.gov |
| February 9, 2018 | K171179 | BR Type Implant System | DZE | Substantially Equivalent | Biotem Co., Ltd. | accessdata.fda.gov |
| January 31, 2018 | K171297 | AR_N Type Implant System | DZE | Substantially Equivalent | Biotem Co., Ltd. | accessdata.fda.gov |
| December 1, 2017 | K171185 | IR Type Implant System | DZE | Substantially Equivalent | Biotem Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pin, Retentive And Splinting, And Accessory Instruments
- All makers of Drill, Dental, Intraoral
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Gauge, Depth, Instrument, Dental
- All makers of Accessories, Implant, Dental, Endosseous
Updated June 24, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.