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Root Canal Files
EUDAMEDClass IIa (EU MDR)
Ref V08 2306 031 015Model V-TAPER ROTARY/V-TAPER GOLD/V-TAPER BLUE/V-TAPER NXT
Identity
- Device Name
- ROOT CANAL FILES EUDAMED
- Model / Reference
- V-TAPER ROTARY/V-TAPER GOLD/V-TAPER BLUE/V-TAPER NXT EUDAMEDV08 2306 031 015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942049501060 EUDAMED
- Basic UDI-DI
- 697492976V0006NE EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Manual endodontic file/rasp, reusable
Root Canal Files by Shanghai Fanta Dental Materials Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Manual endodontic file/rasp, reusable.
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- KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
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 | 697492976V0006NE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai Fanta Dental Materials Co., Ltd
- EUDAMED SRN
- CN-MF-000017176
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED b3057c1a-a0ed-41ec-ae07-6168e3623856 61 fields · synced Jun 18, 2026