Organization name

OSSTEM IMPLANT CO.,LTD

SRN

KR-MF-000021655

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• [Contraindications] The device shall not be used for any purpose other than its intended use. There are no known contraindications associated with this device, as the technology operates within controlled and internationally accepted safety standards.

  OTHER

• Patients must wear a lead apron and thyroid collar during imaging for radiation protection. Children, pregnant women, breastfeeding women, and women of childbearing potential must always wear these protective items. - Each imaging request must be reviewed and justified by a qualified dentist before exposure. - If the operator encounters an unusual or unclear imaging request, he or she must consult the responsible dentist before proceeding. - When imaging pediatric patients, the operator should optimize exposure parameters according to patient size to minimize radiation dose. - All pediatric patients shall be shielded during X-ray exposure, except when shielding interferes with diagnostic objectives or is clinically unreasonable. - To reduce patient motion during imaging, especially in children, use distraction techniques such as child-friendly themes, music, visual aids through the console window.

  OTHER

Primary placement in Czechia; available across 32 countries total.

Trade name

not provided

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08800000995618

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

8800406T2SY

Reference / catalog number

T2-CS

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

T2-C, T2-CS are computed tomography X-ray system intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy on a real time basis by computer reconstruction of X-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry. The device is operated and used by physicians, dentists, and X-ray technicians.

Additional information URL

https://ifu.osstem.com/ifu/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z11030607COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE

• Class IIb medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.