Data / Medical devices / South Korea / Neobiotech Co., Ltd.
Neobiotech Co., Ltd.: FDA-registered device maker in Wonju-si Gangwon, South Korea, 14 510(k) clearances
Neobiotech Co., Ltd. is registered with the FDA (registration 3004730368) in Wonju-si Gangwon, South Korea. It lists 9 device types. The FDA files 14 510(k) clearances under its listings, the newest dated April 30, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004730368
- Address
- 70, Sinpyeong-ro, Jijeong-myeon, Wonju-si Gangwon, South Korea, 26351
- Owner or operator
- NEOBIOTECH CO., LTD. (9066035)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- August 25, 2008
- Registered through
- 2027
- Brand names listed
- 3D Former, ACM Stopper, ALX Bone Trimmer, ALX MAXY, ALX MD Parallel Pin, ALX Margin Profile, ALX Parallel Pin, ALX Taper Drill 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 |
| Facebow | KCR | 1 | Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Exporter to the US | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Intraosseous | DZL | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 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 |
|---|---|---|---|---|---|---|
| April 30, 2024 | K232528 | Protective Cap | NHA | Substantially Equivalent | Neobiotech Co., Ltd. | accessdata.fda.gov |
| March 28, 2024 | K232049 | IS-III active Short Implant | DZE | Substantially Equivalent | Neobiotech Co., Ltd. | accessdata.fda.gov |
| July 23, 2021 | K210903 | IS Multi Unit Abutment System | NHA | Substantially Equivalent | Neobiotech Co., Ltd. | accessdata.fda.gov |
| August 14, 2019 | K190849 | IS-III active System_S-narrow Type | DZE | Substantially Equivalent | Neobiotech Co., Ltd. | accessdata.fda.gov |
| February 20, 2019 | K180953 | AnyCheck IMT-100 | EKX | Substantially Equivalent | Dms Co., Ltd. | accessdata.fda.gov |
| November 16, 2018 | K181137 | IT-III active System | DZE | Substantially Equivalent | Neobiotech Co., Ltd. | accessdata.fda.gov |
| October 3, 2018 | K181138 | IS-III active System | DZE | Substantially Equivalent | Neobiotech Co., Ltd. | accessdata.fda.gov |
| May 24, 2018 | K173938 | IS-III HActive Fixture | DZE | Substantially Equivalent | Neobiotech Co., Ltd. | accessdata.fda.gov |
| January 10, 2017 | K160991 | Neo GBR System | DZL | Substantially Equivalent | Neobiotech Co., Ltd. | accessdata.fda.gov |
| June 18, 2012 | K120503 | CMI IMPLANT IS II ACTIVE | DZE | Substantially Equivalent | Neobiotech Co., Ltd. | accessdata.fda.gov |
| April 5, 2012 | K113554 | CMI IMPLANT IS SYSTEM | DZE | Substantially Equivalent | Neobiotech Co., Ltd. | accessdata.fda.gov |
| February 3, 2012 | K112540 | S-MINI IMPLANT SYSTEM | DZE | Substantially Equivalent | Neobiotech Co., Ltd. | accessdata.fda.gov |
| August 28, 2009 | K090377 | SINUS QUICK EB SYSTEM | DZE | Substantially Equivalent | Neobiotech Co., Ltd. | accessdata.fda.gov |
| July 14, 2009 | K090527 | SINUS QUICK IT SYSTEM | DZE | Substantially Equivalent | Neobiotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Screw, Fixation, Intraosseous
- All makers of Guide, Surgical, Instrument
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Facebow
Updated April 30, 2024. 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.