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Edge BioCeramic ThermalFlow
EUDAMEDClass IIa (EU MDR)
Ref USEBIOTFEUModel iRSP 08 K1-1
Identity
- Trade Name
- Edge BioCeramic ThermalFlow EUDAMED
- Device Name
- iRoot SP Injectable Root Canal Sealer EUDAMED
- Model / Reference
- iRSP 08 K1-1 EUDAMEDUSEBIOTFEU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540276321513 EUDAMED
- Basic UDI-DI
- 7540276SP4608RA EUDAMED
- EMDN Code
- Q01010202 ROOT CANAL FILLING DENTAL CEMENTS 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: Calcium hydroxide dental cement
Edge BioCeramic ThermalFlow 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 | 7540276SP4608RA | 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 ed5979ef-bf99-443d-b9cd-8d156e17c568 61 fields · synced Jun 18, 2026