Identity
- Trade Name
- Torque Extension EUDAMEDFDA UDI
- Generic Name
- Dental drill bit extension FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- OTE EUDAMEDFDA UDIHOTE EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000958163 EUDAMEDFDA UDI08809892363758 EUDAMEDFDA UDI08800209371633 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental drill bit extension FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Torque Extension by Osstem Implant Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000406CLASSIBS25V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
- EUDAMED SRN
- KR-MF-000020006
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (6)
- EUDAMED 4ae9a9a6-7594-41b3-9d29-b92a76737c3a 61 fields · synced Jul 15, 2026
- FDA UDI cf9c5bf2-85b5-4612-8d2b-3fcaf99f679d 32 fields · synced May 30, 2026
- FDA UDI 9a9ade59-813a-47e5-8d67-b6f3b3c7f42a 32 fields · synced May 30, 2026
- FDA UDI 59cf4175-e5ac-4de7-8530-95dd83a07942 32 fields · synced May 30, 2026
- EUDAMED 982b1ed3-9eb8-4e8c-9864-6a6782fd35d6 61 fields · synced Jul 10, 2026
- EUDAMED 8c3ecaaf-2314-4bca-bac2-1378c9c7e873 61 fields · synced Jul 15, 2026