← Back to catalogue
K File
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ZKF31ASST1Model K File 31mm 15-40 (6 units)Ref ZKFILE3150Model K File 31mm 50 (6 units)Ref ZKF31ASST2Model K File 31mm 45-80 (6 units)Ref ZKFILE2155Model K File 21mm 55 (6 units)Ref ZKFILE3130Model K File 31mm 30 (6 units)Ref ZKFILE2555Model K File 25mm 55 (6 units)Ref ZKFILE3145Model K File 31mm 45 (6 units)Ref ZKFILE2140Model K File 21mm 40 (6 units)Ref ZKFILE2160Model K File 21mm 60 (6 units)Ref ZKFILE2570Model K File 25mm 70 (6 units)Ref ZKFILE2135Model K File 21mm 35 (6 units)Ref TKZKFILE2510Model K File 25mm 10 Zarc Training Kit
Identity
- Trade Name
- K File EUDAMEDZARC FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Device Name
- K File EUDAMED
- Model / Reference
- K File 31mm 15-40 (6 units) EUDAMEDZKF31ASST1 EUDAMEDK File 31mm 50 (6 units) EUDAMEDZKFILE3150 EUDAMEDK File 31mm 45-80 (6 units) EUDAMEDZKF31ASST2 EUDAMEDK File 21mm 55 (6 units) EUDAMEDZKFILE2155 EUDAMEDK File 31mm 30 (6 units) EUDAMEDZKFILE3130 EUDAMEDK File 25mm 55 (6 units) EUDAMEDZKFILE2555 EUDAMEDK File 31mm 45 (6 units) EUDAMEDZKFILE3145 EUDAMEDK File 21mm 40 (6 units) EUDAMEDZKFILE2140 EUDAMEDK File 21mm 60 (6 units) EUDAMEDZKFILE2160 EUDAMEDK File 25mm 70 (6 units) EUDAMEDZKFILE2570 EUDAMEDK File 21mm 35 (6 units) EUDAMEDZKFILE2135 EUDAMEDK File 25mm 10 Zarc Training Kit EUDAMEDTKZKFILE2510 EUDAMEDK File 31mm 30 Zarc (6 units) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975718051245 EUDAMED06942512501580 EUDAMED06975718051252 EUDAMED06942512501498 EUDAMED06975718051207 EUDAMEDFDA UDI06942512501542 EUDAMED06975718051238 EUDAMED06975718050972 EUDAMED06942512501504 EUDAMED06942512501566 EUDAMED06975718050965 EUDAMED06942512509661 EUDAMED
- Basic UDI-DI
- B-06975718051245 EUDAMEDB-06942512501580 EUDAMEDB-06975718051252 EUDAMEDB-06942512501498 EUDAMEDB-06975718051207 EUDAMEDB-06942512501542 EUDAMEDB-06975718051238 EUDAMEDB-06975718050972 EUDAMEDB-06942512501504 EUDAMEDB-06942512501566 EUDAMEDB-06975718050965 EUDAMEDB-06942512509661 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
- GMDN Term
- Manual 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
- Spain 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
K File by Shenzhen Denco Medical Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06975718051245 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (13)
- EUDAMED 4ae997ef-4f09-418f-b621-37e1c8c5cf0b 61 fields · synced Jul 26, 2026
- EUDAMED 179ddda6-e2ba-4271-8c10-91867f43e3e4 61 fields · synced May 11, 2026
- EUDAMED 92a8c180-7c52-400e-9b08-87ec46634c24 61 fields · synced May 16, 2026
- EUDAMED 312a4e18-5536-4514-9d3b-a3d19f68a502 61 fields · synced May 16, 2026
- EUDAMED c692cfea-8ff9-4eaa-b4a3-08e537074d01 61 fields · synced May 17, 2026
- EUDAMED f3571bcf-da21-4580-aaef-8d840594ef8e 61 fields · synced May 17, 2026
- EUDAMED 4693798a-d06d-432b-8527-d9bc8977b578 61 fields · synced May 17, 2026
- EUDAMED 051252e5-9246-46c1-afdf-a5c30a87720a 61 fields · synced May 17, 2026
- EUDAMED 6db5524d-c94e-4d53-85f6-71887a93da83 61 fields · synced May 17, 2026
- EUDAMED 9c0de208-b932-4a62-9b11-ecbe26270354 61 fields · synced May 17, 2026
- EUDAMED ebadef62-6fb0-4a8e-8f5d-d7c08069cd5a 61 fields · synced May 18, 2026
- EUDAMED 27786c3a-823b-410d-9c1b-bd405a8733b6 61 fields · synced May 19, 2026
- FDA UDI dd7ecff5-63c9-476a-98a5-b51e3f21bdac 33 fields · synced May 30, 2026