Identity
- Trade Name
- RGI - XFast 2.0 Caps EUDAMED
- Device Name
- RGI - XFast 2.0 Caps EUDAMED
- Model / Reference
- 9007998 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D92590079981 EUDAMED
- Basic UDI-DI
- ++D9250209001103897XQ EUDAMED
- EMDN Code
- Q01010106 DENTAL RESTORATION GLASS IONOMERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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: Glass ionomer dental cement
RGI - XFast 2.0 Caps by CB Dental Reg. GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Glass ionomer dental cement.
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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 | ++D9250209001103897XQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- CB Dental Reg. GmbH
- EUDAMED SRN
- DE-MF-000005407
Sources (1)
- EUDAMED 1e5752c1-9c9d-4a4e-8c7a-dc283e46e879 61 fields · synced Jul 29, 2026