Identity
- Trade Name
- T2 EUDAMEDFDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Dental X-ray System EUDAMED
- Model / Reference
- T2-CS EUDAMEDFDA UDIT2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800000995618 EUDAMEDFDA UDI
- Basic UDI-DI
- 8800406T2SY EUDAMEDB-08800000995618 EUDAMED
- 510(k) Number
- K212303 FDA UDI
- FDA Product Code
- OAS FDA UDI
- EMDN Code
- Z11030607 COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE EUDAMED
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Market of Registration
- Czechia EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Stationary panoramic/tomographic dental x-ray system, digital
T2 by OSSTEM IMPLANT Co., Ltd. — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
Sources (3)
- FDA UDI 4c3481b6-0bb1-4b04-8204-09c823fcb229 33 fields · synced Oct 8, 2026
- EUDAMED 6497d09c-da84-4645-a50a-04376f5ce7ef 61 fields · synced Oct 7, 2026
- EUDAMED 4d4d8b31-7c00-403f-93da-83269c4ab6d3 61 fields · synced Oct 8, 2026