EdgeUtopia RRM 1.5 g
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- EdgeUtopia RRM 1.5 g EUDAMEDEdgeUtopia Repair Material FDA UDI
- Generic Name
- Hygroscopic dental cement FDA UDI
- Device Name
- Bioceramic reparative material ready-to-use. FDA UDI
- Model / Reference
- Bioceramics EUDAMED38632 EUDAMEDEdgeUtopia Repair Material 1.5 g FDA UDI
- Description
- Bioceramic reparative material ready-to-use. FDA UDI
Identifiers
- Catalog Number
- 38632 FDA UDI
- Primary DI / UDI-DI
- 07898078655214 EUDAMEDFDA UDI
- Basic UDI-DI
- 807865BIOCERAMICSQN EUDAMED
- FDA Product Code
- KIF FDA UDI
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS EUDAMED
- GMDN Term
- Hygroscopic dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3820 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Calcium hydroxide dental cement
EdgeUtopia RRM 1.5 g by Angelus Indústria De Produtos Odontológicos S/A — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 807865BIOCERAMICSQN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Angelus Indústria De Produtos Odontológicos S/A
- EUDAMED SRN
- BR-MF-000010255
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED dbd7f1fb-78e2-4897-8e10-3ea85be53b7b 61 fields · synced Jul 15, 2026
- FDA UDI dca856ac-7a80-4815-9d7e-53f793ca15a6 35 fields · synced May 30, 2026