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Endo Rotary file
EUDAMEDFDA UDIClass I (EU MDR)
Ref K file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal fileModel K file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal file, OK file, OH file,Taper file, Compliant file and RT fill.
Identity
- Trade Name
- Endo Rotary file EUDAMEDFDA UDI
- Generic Name
- Margin finishing dental file/rasp, reusable FDA UDI
- Device Name
- Endo Rotary file EUDAMEDK file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal file, OK file, OH file,Taper file, Compliant file and RT fill. FDA UDI
- Model / Reference
- K file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal file, OK file, OH file,Taper file, Compliant file and RT fill. EUDAMEDK file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal file EUDAMEDK file, Machine super file, Machine H file, G file, P file FDA UDI
- Description
- K file, Machine super file, Machine H file, G file, P file, D root canal dredging file, Ultrasonic root canal file, OK file, OH file,Taper file, Compliant file and RT fill. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970873260112 EUDAMEDFDA UDI
- Basic UDI-DI
- 6970873260112AQ EUDAMED
- Direct Marketing DI
- 06970873260112 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
- GMDN Term
- Margin finishing dental file/rasp, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Endo Rotary file by Denjoy Dental Co., Ltd — Class I — 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 | 6970873260112AQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Denjoy Dental Co., Ltd
- EUDAMED SRN
- CN-MF-000044157
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED 30243e57-6731-4860-96e7-8cc65eb57a9d 61 fields · synced Jun 18, 2026
- FDA UDI eedba507-5864-4fab-b8fa-00130741ebe2 33 fields · synced May 30, 2026
- EUDAMED 30243e57-6731-4860-96e7-8cc65eb57a9d-1 61 fields · synced Jun 9, 2026