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CERALOG® PL Implant driver, ISO-shaft L 27.8 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref HP5330.0003
Identity
- Trade Name
- CERALOG® PL Implant driver, ISO-shaft L 27.8 mm EUDAMEDCERALOG® PL Implant driver ISO-shaft, L 27.8 mm FDA UDI
- Generic Name
- Dental implant holding endpiece, reusable FDA UDI
- Device Name
- Pickup EUDAMED
- Model / Reference
- HP5330.0003 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640161397187 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016139XT3XXXXKL2APIFW EUDAMED
- Direct Marketing DI
- 07640161397187 EUDAMED
- FDA Product Code
- EGS FDA UDI
- EMDN Code
- Z12019001 SURGICAL WIRE APPLICATION EQUIPMENT EUDAMEDL159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental implant holding endpiece, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CERALOG® PL Implant driver, ISO-shaft L 27.8 mm by CeramTec Schweiz GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 764016139XT3XXXXKL2APIFW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- CeramTec Schweiz GmbH
- EUDAMED SRN
- CH-MF-000024169
- Authorised Representative
- CeramTec Dentalvertriebs GmbH DE-AR-000020220
Sources (3)
- EUDAMED e0d7ea24-4acb-4655-8f60-281d8c406ffd 61 fields · synced Oct 8, 2026
- FDA UDI e05d5a4b-0bfa-49b5-850d-e8c1e6840627 34 fields · synced May 30, 2026
- EUDAMED 219301ac-599d-4540-a65a-2f27a1c3ce54 61 fields · synced Oct 8, 2026