Neobiotech
Also known as: Neobiotech Co., Ltd., Neo Biotech
A South Korean manufacturer founded in 2000, maker of the CMI SinusQuick surgical kits and the IS-II/IS-III implant families.
Key facts
| Manufacturer | Neobiotech Co., Ltd.Verified spec[1] |
|---|---|
| Country | South KoreaVerified spec[1] |
| Headquarters | Seoul, South Korea (Guro-gu), per its US regulatory filingsVerified spec[1] |
| Founded | July 2000Manufacturer-reported[2] |
| manufacturingCountry | South KoreaVerified spec[3]Country of the FDA-registered device establishment, which may differ from the brand’s home country. |
Overview
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance15 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K232528 | Protective Cap | Neobiotech Co., Ltd. | 2024-04-30 |
| K232049 | IS-III active Short Implant | Neobiotech Co., Ltd. | 2024-03-28 |
| K210903 | IS Multi Unit Abutment System | Neobiotech Co., Ltd. | 2021-07-23 |
| K190849 | IS-III active System_S-narrow Type | Neobiotech Co., Ltd. | 2019-08-14 |
| K181137 | IT-III active System | Neobiotech Co., Ltd. | 2018-11-16 |
| K181138 | IS-III active System | Neobiotech Co., Ltd. | 2018-10-03 |
| K181178 | S-mini active Fixture | Neobiotech Co., Ltd. | 2018-07-24 |
| K173938 | IS-III HActive Fixture | Neobiotech Co., Ltd. | 2018-05-24 |
| K120503 | CMI IMPLANT IS II ACTIVE | Neobiotech Co., Ltd. | 2012-06-18 |
| K113554 | CMI IMPLANT IS SYSTEM | Neobiotech Co., Ltd. | 2012-04-05 |
| K112540 | S-MINI IMPLANT SYSTEM | Neobiotech Co., Ltd. | 2012-02-03 |
| K090377 | SINUS QUICK EB SYSTEM | Neobiotech Co., Ltd. | 2009-08-28 |
| K090825 | SQ IS SYSTEM | Neobiotech Co., Ltd. | 2009-07-16 |
| K090527 | SINUS QUICK IT SYSTEM | Neobiotech Co., Ltd. | 2009-07-14 |
| K042339 | NEOPLANT IMPLANT SYSTEM | Neobiotech Co., Ltd. | 2004-11-02 |
Other2 records
Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.
| Number | Device | Holder | Date |
|---|---|---|---|
| 3004730368 | — | NEOBIOTECH CO., LTD. | — |
| 483 device records | — | Neobiotech | — |
Clearance records for Neobiotech were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Neobiotech.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]FDA 510(k) K181138 — IS-III active System — U.S. Food & Drug Administration, 2018. Accessed 2026-07-21.
- [2]Neobiotech — Company Introduction — Neobiotech Co., Ltd.. Accessed 2026-07-21.
- [3]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.