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Edge BioCeramic RetroFill
EUDAMEDClass IIa (EU MDR)
Ref USEBIORMEUModel iRBPP 4610 U5-
Identity
- Trade Name
- Edge BioCeramic RetroFill EUDAMED
- Device Name
- iRoot BP Plus Root Repair Material EUDAMED
- Model / Reference
- iRBPP 4610 U5- EUDAMEDUSEBIORMEU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540276340514 EUDAMED
- Basic UDI-DI
- 7540276BPP4610MP EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 coating, tooth-desensitizing
Edge BioCeramic RetroFill by Innovative BioCeramix Inc. — Class IIa — 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 | 7540276BPP4610MP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Innovative BioCeramix Inc.
- EUDAMED SRN
- CA-MF-000023003
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 4b26000e-a69b-45cc-a2b9-5e1e73d950f1 61 fields · synced Jul 23, 2026