Identity
- Trade Name
- PORCELAIN FIX EUDAMEDFDA UDI
- Generic Name
- Dental prosthesis priming agent FDA UDI
- Device Name
- Ceramic Surface Treatments EUDAMEDSingle package containing 2 syringes Porcelain Etch and 2 bottles Porcelain Silane FDA UDI
- Model / Reference
- 400084 EUDAMEDFDA UDI
- Description
- Single package containing 2 syringes Porcelain Etch and 2 bottles Porcelain Silane FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290115050448 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011505400084AZ EUDAMED
- Unit of Use DI
- 07290115052824 EUDAMED
- 510(k) Number
- K933766 FDA UDI
- FDA Product Code
- KLE FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental prosthesis priming agent FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3200 FDA UDI
- Market of Registration
- Belgium 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Porcelain Fix by B.J.M. Laboratories Ltd. — Class IIa — 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 | 729011505400084AZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- B.J.M. Laboratories Ltd.
- EUDAMED SRN
- IL-MF-000034121
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED f3354e84-3534-452c-95c2-879af5b27f02 61 fields · synced Jul 14, 2026
- FDA UDI 499b78d5-c4e0-4301-b163-54b6a5284a1e 36 fields · synced May 30, 2026