Identity
- Trade Name
- Plicafol EUDAMEDFDA UDI
- Generic Name
- Wax dental impression material FDA UDI
- Device Name
- Plicafol EUDAMEDPlaceholder film for dental film impressions FDA UDI
- Model / Reference
- 03910 EUDAMEDFDA UDI
- Description
- Placeholder film for dental film impressions FDA UDI
Identifiers
- Catalog Number
- 03910 FDA UDI
- Primary DI / UDI-DI
- +EBIB039101 EUDAMEDEBIB039101 FDA UDI
- Basic UDI-DI
- ++EBIB039PLIC7T EUDAMED
- Direct Marketing DI
- +EBIB039101 EUDAMED
- FDA Product Code
- EGD FDA UDI
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Wax dental impression material FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6890 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Plicafol by bisico Bielefelder Dentalsilicone GmbH & Co. KG — 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
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EBIB039PLIC7T | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++EBIB039PLIC7T | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bisico Bielefelder Dentalsilicone GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000011554
Sources (2)
- EUDAMED 6ec104c4-5938-4b63-8215-8a312cb40b29 61 fields · synced Jun 8, 2026
- FDA UDI eebd1122-144e-4ed5-aae3-8a6e4a63a500 36 fields · synced May 30, 2026