Identifiers
- 510(k) Number
- K181137 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The IT-III Active System is an internal non-submerged type and tissue level implant product that simplifies implantation depth control. It features an SLA surface that minimizes the osseointegration period and a smooth body design that maximizes initial stability for prosthetic loading or AnyTime Loading.
The IT-III Active System is supplied as a dental implant with fixture options featuring dual gingiva collar types of 1.8mm and 2.8mm to accommodate various gingival heights. It has received FDA 510(k) clearance with the product code DZE and is manufactured by Neobiotech Co., Ltd. in Seoul, Korea.
Frequently asked questions
What is the IT-III Active System used for?
The IT-III Active System is an internal non-submerged dental implant designed for tissue level placement. It features an SLA surface that minimizes osseointegration time and a smooth body design that maximizes initial stability for prosthetic loading or AnyTime Loading procedures.
What gingiva collar options are available with the IT-III Active System?
The IT-III Active System is supplied with dual gingiva collar types measuring 1.8mm and 2.8mm, allowing clinicians to accommodate various gingival heights for optimal patient outcomes.
Is the IT-III Active System cleared for use in the United States?
Yes, the IT-III Active System has received FDA 510(k) clearance with product code DZE. It was determined to be substantially equivalent to predicate devices and is manufactured by Neobiotech Co., Ltd. in Seoul, Korea.
What surface technology does the IT-III Active System feature?
The IT-III Active System utilizes an SLA (sandblasted, large-grit, acid-etched) surface treatment that minimizes the osseointegration period, allowing for potentially faster healing times compared to traditional implant surfaces.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: IT-III Active - Neobiotech, IS-III Active - Neobiotech, IT-III Active Fixture - NeoBiotech USA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181137 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neobiotech. co., ltd
- FDA Applicant
- Neobiotech Co., Ltd.
Sources (1)
- FDA 510(k) K181137 24 fields · synced Sep 25, 2026