Neobiotech IS-III active
Also known as: IS-III active, CMI IS-III
A tapered, internal-hex bone-level implant from Neobiotech with an SLA surface, designed for high primary stability.
Quick facts
| Manufacturer | Neobiotech Co., Ltd.Verified spec[1] |
|---|---|
| Implant level | Bone-levelVerified spec[1] |
| Body geometry | Tapered (root-form) fixtureVerified spec[1] |
| Material | Grade-4 commercially pure titanium (ASTM F67)Verified spec[1] |
| Surface | SLA — sandblasted with large grit and acid-etchedVerified spec[1] |
| Connection | Internal hexVerified spec[1] |
| Available diameters | Ø3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 mmVerified spec[1] |
| Available lengths | 7.3, 8.5, 10.0, 11.5, 13.0 and 15.0 mm (the Ø3.5 fixture starts at 8.5 mm; the widest fixtures stop at 13.0 mm)Verified spec[1] |
Overview
Technology
Clinical positioning
What the manufacturer says this system is designed for. This is not the same thing as independent clinical evidence, which is set out separately below.
Further detail
| Country | South KoreaVerified spec[1] |
|---|
Clinical evidence
We have not yet completed a system-specific evidence review for Neobiotech IS-III active. Insufficient system-specific evidence How we grade evidence
Similar implant systems
The clearances below are held by Neobiotech at brand level and cover its implant range, not Neobiotech IS-III active specifically. We show them here because that is the level at which regulators actually issue them.
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) clearance4 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
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.