Porcelain Etch
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- PORCELAIN ETCH EUDAMEDFDA UDI
- Generic Name
- Dental prosthesis priming agent FDA UDI
- Device Name
- Ceramic Surface Treatments EUDAMED
- Model / Reference
- 400082IT EUDAMED400082 EUDAMEDFDA UDI400082SA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115050820 EUDAMED07290115050479 EUDAMEDFDA UDI07290115053654 EUDAMED
- 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
Single Use
No
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Total Volume — 2.4 Milliliter FDA UDI
Category: Dental appliance fabrication material, ceramic
Porcelain Etch by B.J.M. Laboratories Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, ceramic.
- Razor / MegaPlus — U&C International Co., Ltd · Class II
- rainbow High shine — Genoss · Class II
- Bloomden — Bloomden Bioceramics (Hunan) Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
- CGI — CERAGROUP INDUSTRIES · Class II
- ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- B.J.M. Laboratories Ltd.
- EUDAMED SRN
- IL-MF-000034121
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED 70f9b060-0843-4794-83d8-9e56b8983802 61 fields · synced Jul 31, 2026
- EUDAMED 385482f3-a7c8-4bf9-964f-cbe286bc6821 61 fields · synced May 16, 2026
- EUDAMED 139c618b-2361-4fe0-82dd-c135eb81f1a8 61 fields · synced May 19, 2026
- FDA UDI a13bb972-3692-49a5-ac8e-a2aa7398a1cf 35 fields · synced May 30, 2026