← Back to catalogue
Countersink
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref D4UCSRef TCS60Ref TCS40Ref TCS50TP
Identity
- Trade Name
- Countersink EUDAMEDFDA UDICounter Sink EUDAMED
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Surgical Drill System EUDAMED
- Model / Reference
- D4UCS EUDAMEDFDA UDITCS60 EUDAMEDTCS40 EUDAMEDTCS50TP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800040628033 EUDAMEDFDA UDI08800271283070 EUDAMED08800271283018 EUDAMED08800271283049 EUDAMED
- Basic UDI-DI
- 88000406DRILLH5 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
Countersink by Osstem Implant Co., Ltd. — Class IIa — 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 | 88000406DRILLH5 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (5)
- EUDAMED 9f5dd1d7-512b-463f-b3a6-868b83f64f50 61 fields · synced Jul 30, 2026
- FDA UDI c7f22a09-c64e-4a7a-88a4-3010af7e663b 32 fields · synced May 30, 2026
- EUDAMED b5a0756a-caa4-45ff-8b4f-4f83e9aadea4 61 fields · synced Jul 12, 2026
- EUDAMED bcdf49e9-5cc2-4692-adae-84c5049a5e54 61 fields · synced Jul 20, 2026
- EUDAMED 179cdae1-edd9-4934-8d25-9aa7844ab32d 61 fields · synced Jul 30, 2026