CERALOG® PL Impression post closed tray Ø 5.0 mm L 7.8 mm
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- CERALOG® PL Impression post closed tray Ø 5.0 mm L 7.8 mm EUDAMEDCERALOG® PL Impression post closed tray, Ø 5.0 mm L 7.8 mm 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 5.0 mm L 7.8 mm FDA UDI
- Model / Reference
- HP2140.5008 EUDAMEDFDA UDI
- Description
- CERALOG® PL Impression post closed tray, Ø 5.0 mm L 7.8 mm FDA UDI
Identifiers
- Catalog Number
- HP2140.5008 FDA UDI
- Primary DI / UDI-DI
- 07640161396951 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, single-use
CERALOG® PL Impression post closed tray Ø 5.0 mm L 7.8 mm by CeramTec Schweiz GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 a4922022-aa7e-4f3b-a106-4a848c6f9fd2 61 fields · synced Oct 6, 2026
- FDA UDI d60b3c7e-3d5e-4161-9866-075911ba199c 35 fields · synced May 30, 2026