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Excellent Solid Abutment Driver
EUDAMEDFDA UDIClass I (EU MDR)
Ref ESDSSRef HESDRSRef HESD60SRef HESDSS
Identity
- Trade Name
- Excellent Solid Abutment Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- ESDSS EUDAMEDFDA UDIHESDSS EUDAMEDFDA UDIHESD60S EUDAMEDFDA UDIHESDRS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800040622444 EUDAMEDFDA UDI08800209366639 EUDAMEDFDA UDI08800209366592 EUDAMEDFDA UDI08800209366615 EUDAMEDFDA UDI
- 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
Excellent Solid Abutment 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 530a731c-179d-4cc3-b995-c7c0707cc63b 61 fields · synced Jul 26, 2026
- FDA UDI fd0e13ac-0217-4b42-881e-51d30694542a 32 fields · synced May 29, 2026
- FDA UDI 1f085c76-c7a3-441d-ac07-450af9d504f2 32 fields · synced May 30, 2026
- FDA UDI abd4a197-da0e-48a5-bbe3-a58b69a5e964 32 fields · synced May 30, 2026
- FDA UDI bb4f27cd-5e64-4eb7-b473-1bfb08a2a878 32 fields · synced May 30, 2026
- EUDAMED d7161a8a-588b-4a12-a6aa-b06f961a6b81 61 fields · synced Jul 13, 2026
- EUDAMED 982144d2-11b9-4cae-9007-b8515494b5bb 61 fields · synced Jul 25, 2026
- EUDAMED 2a5e1029-daad-420c-a9e6-9aa36cd437bd 61 fields · synced Jul 26, 2026