Identity
- Trade Name
- Mount Extension EUDAMEDFDA UDI
- Generic Name
- Dental drill bit extension FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- ASMEL EUDAMEDFDA UDIASMES EUDAMEDFDA UDIHASMES EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000931395 EUDAMEDFDA UDI08800209393024 EUDAMEDFDA UDI08800209366127 EUDAMEDFDA UDI08800209393017 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
Mount 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
- EUDAMED SRN
- KR-MF-000020006
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (8)
- EUDAMED a297d722-c339-46fc-94cc-5d591988a4ad 61 fields · synced Jul 21, 2026
- FDA UDI 3535c067-eb03-4e88-b50f-1e9cd184059a 32 fields · synced May 30, 2026
- FDA UDI 59e03b79-6066-4845-bf7a-41ad4de8d25d 32 fields · synced May 30, 2026
- FDA UDI 5e1bba12-df44-4dd3-9f79-80bb7d18842f 32 fields · synced May 30, 2026
- FDA UDI 6d345605-21d9-4bc4-9234-87e520a05077 32 fields · synced May 30, 2026
- EUDAMED f934a037-5a53-4658-8ac6-ee69a7fa401e 61 fields · synced Jul 10, 2026
- EUDAMED 8bec171c-9c61-4c16-8f2a-cb55e3f2414c 61 fields · synced Jul 13, 2026
- EUDAMED 65063c73-2306-4179-94c8-48ca18d45d25 61 fields · synced Jul 21, 2026