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Abutment Positioning Driver
EUDAMEDFDA UDIClass I (EU MDR)
Ref OAPDSRef HKAPDSRef HAPDSRef HKAPDLRef OAPDL
Identity
- Trade Name
- Abutment Positioning Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- OAPDS EUDAMEDFDA UDIOAPDL EUDAMEDFDA UDIHAPDS EUDAMEDFDA UDIHKAPDS EUDAMEDHKAPDL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800209337196 EUDAMEDFDA UDI08809917158482 EUDAMEDFDA UDI08809917158512 EUDAMEDFDA UDI08809917158406 EUDAMED08809917158390 EUDAMED
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable 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
Abutment Positioning Driver 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 (8)
- EUDAMED cdb6ef3b-6e16-4e6f-a6b7-330b70ac25ad 61 fields · synced Jul 28, 2026
- FDA UDI 2ed0bfc2-d779-43d4-8f3c-2d38095dd8e7 32 fields · synced May 30, 2026
- FDA UDI 567bb8e4-a478-498c-937b-a5f512ac1e3d 32 fields · synced May 30, 2026
- FDA UDI edae0abd-9dea-4853-af34-335213bb758c 32 fields · synced May 30, 2026
- EUDAMED 8564d722-f15b-4976-bb63-66562cb0f556 61 fields · synced Jul 9, 2026
- EUDAMED d74ec713-44a0-4ea8-84dc-57118c7add4a 61 fields · synced Jul 9, 2026
- EUDAMED 9b483ab5-5687-48a0-9688-c685fa5a0137 61 fields · synced Jul 10, 2026
- EUDAMED ddcc8530-7cdf-4081-838f-8486603edfd0 61 fields · synced Jul 28, 2026