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Edge X7 Utopia
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref S1.UB1.00.0AH.EEModel S1.7B0.00.0FI.FK
Identity
- Trade Name
- EDGE X7 UTOPIA EUDAMEDFDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
- Device Name
- R-Motion EUDAMEDEdge X7 Utopia no 45, 04, 21mm FDA UDI
- Model / Reference
- S1.7B0.00.0FI.FK EUDAMEDS1.UB1.00.0AH.EE EUDAMEDX7U450421SE FDA UDI
- Description
- Edge X7 Utopia no 45, 04, 21mm FDA UDI
Identifiers
- Catalog Number
- X7U450421SE FDA UDI
- Primary DI / UDI-DI
- 07640142444930 EUDAMEDFDA UDI
- Basic UDI-DI
- 7640142410401019R EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
- GMDN Term
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Edge X7 Utopia by FKG Dentaire Sàrl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7640142410401019R | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- FKG Dentaire Sàrl
- EUDAMED SRN
- CH-MF-000017925
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d1ec2d56-cd94-4c84-aa1f-189f8d323d1f 61 fields · synced Jul 10, 2026
- FDA UDI ccc4aef4-0502-42bc-8392-f3cf33549d1e 34 fields · synced May 30, 2026