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CERALOG® PL Impression post closed tray, long Ø 3.8 mm L 11.8 mm
EUDAMEDFDA UDIClass I (EU MDR)
Ref HP2141.3812
Identity
- Trade Name
- CERALOG® PL Impression post closed tray, long Ø 3.8 mm L 11.8 mm EUDAMEDCERALOG® PL Impression post closed tray, Ø 3.8mm L 11.8mm FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Accessories for prosthetic restoration EUDAMEDCERALOG® PL Impression post closed tray, Ø 3.8mm L 11.8mm FDA UDI
- Model / Reference
- HP2141.3812 EUDAMEDFDA UDI
- Description
- CERALOG® PL Impression post closed tray, Ø 3.8mm L 11.8mm FDA UDI
Identifiers
- Catalog Number
- HP2141.3812 FDA UDI
- Primary DI / UDI-DI
- 07640161396760 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016139XB3YYYYK01IPET EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, 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
CERALOG® PL Impression post closed tray, long Ø 3.8 mm L 11.8 mm by CeramTec Schweiz GmbH — Class I — 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 | 764016139XB3YYYYK01IPET | 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 4175ee58-1478-4c83-adfc-9650b2e6f5a6 61 fields · synced Jul 22, 2026
- FDA UDI 86d6b3ae-5afd-4018-9e91-43d8be735f06 35 fields · synced May 30, 2026