T2 Plus

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K233806

Identifiers

510(k) Number: K233806 FDA 510(k)
FDA Product Code: OAS FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 892.1750 FDA 510(k)
Regulation Number: 892.1750 FDA 510(k)
Advisory Committee: Radiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The T2 Plus is a Computed Tomography X-Ray System for Dental Use, designed to provide panoramic, cone-beam computed tomography (CBCT), and cephalometric imaging. It is classified as a Class II medical device under 21 CFR 892.1750 and is intended for radiographic imaging in dental radiology applications.

This device is supplied as a reusable, multi-modal imaging system for dental offices and clinics. It operates under FDA 510(k) clearance and MDD compliance, with no third-party certification indicated. The system is intended for use in controlled environments where precise imaging of dental structures is required, and it is regulated under the Product Code OAS. Storage and handling follow standard medical imaging protocols to ensure optimal performance and safety.

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: PDF September 6, 2024 - accessdata.fda.gov, K233806 - T2 Plus | FDA 510(k) | Osstem Implant Co., Ltd., T2 CBCT (Pano, CT, Ceph) - Hiossen Implant USA eShop, Osstem Implant - T2 Plus - dental-tribune.com

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K233806	Class II	Active

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Manufacturer

Manufacturer: Osstem Implant Co., Ltd.

Sources (2)

FDA 510(k) K233806 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026