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CERALOG® PL Rescue-Shell Ø 5.0 mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref HP5900.2030
Identity
- Trade Name
- CERALOG® PL Rescue-Shell Ø 5.0 mm EUDAMEDCERALOG® PL Rescue Shell Ø 5.0 FDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- Rescue-Shell EUDAMEDCERALOG® PL Rescue Shell Ø 5.0 FDA UDI
- Model / Reference
- HP5900.2030 EUDAMEDFDA UDI
- Description
- CERALOG® PL Rescue Shell Ø 5.0 FDA UDI
Identifiers
- Catalog Number
- HP5900.2030 FDA UDI
- Primary DI / UDI-DI
- 07640161397200 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016139R981XXK01RS5Y EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Surgical drill guide, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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 Rescue-Shell Ø 5.0 mm by CeramTec Schweiz GmbH — 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 | 764016139R981XXK01RS5Y | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (2)
- EUDAMED 286b6887-2818-4ea9-a2cb-2b6db64f85a4 61 fields · synced Jul 31, 2026
- FDA UDI f4cc4d3f-b665-4e09-8163-03c498139d07 36 fields · synced May 30, 2026