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Denco
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref D-P.03.01-025-02-010-SR-000-00-00Model NITI K-Files 25mm #10 6pcs/pack
Identity
- Trade Name
- NITI K-Files EUDAMEDDenco FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Device Name
- NITI K-Files EUDAMED
- Model / Reference
- NITI K-Files 25mm #10 6pcs/pack EUDAMEDD-P.03.01-025-02-010-SR-000-00-00 EUDAMED25mm Niti K file(For hand) #10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970514910314 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970514910314 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
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual endodontic file/rasp, single-use
Denco by Shenzhen Denco Medical Co., Ltd — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual endodontic file/rasp, single-use.
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- Endodontic Hand Instrument — TULSA DENTAL PRODUCTS LLC · Class I
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- 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- K-Files — TULSA DENTAL PRODUCTS LLC · Class I
- K-REAMERS — TULSA DENTAL PRODUCTS LLC · Class I
- K-Files — TULSA DENTAL PRODUCTS LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd
Sources (2)
- FDA UDI e5506f54-b150-4b0e-8a8f-b51d6ed846fa 32 fields · synced Jun 19, 2026
- EUDAMED b7e61322-131b-4235-9663-e52a9f55b537 61 fields · synced Jun 19, 2026