Identity
- Trade Name
- Porcelain Etch Gel EUDAMED
- Device Name
- Porcelain Etch Gel EUDAMED
- Model / Reference
- PEG-3-NL EUDAMEDPEG-TOP EUDAMED
Identifiers
- Primary DI / UDI-DI
- D701PEG3NL2 EUDAMEDD701PEGTOP2 EUDAMED
- Basic UDI-DI
- ++D701PEGRF EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Dental appliance fabrication material, ceramic
Porcelain Etch Gel by Pulpdent Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D701PEGRF | Class I | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- EUDAMED SRN
- US-MF-000004897
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 894f3d87-3769-4da2-81b1-c5f3c895e6b4 61 fields · synced Jul 15, 2026
- EUDAMED b4ad0f2c-8e0f-46c4-acb7-a16048baa6d3 61 fields · synced May 17, 2026