Identity
- Trade Name
- Root Canal Files EUDAMEDNIC or SUPERLINE FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- Root Canal Files EUDAMEDThe product is used with dental motors, it is intended for cutting, trim and finish natural and engineered dental materials during various dental procedures. FDA UDI
- Model / Reference
- K, H, Reamers EUDAMEDN/A EUDAMEDInverted Cone FDA UDI
- Description
- The product is used with dental motors, it is intended for cutting, trim and finish natural and engineered dental materials during various dental procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944835190281 EUDAMEDFDA UDI
- Basic UDI-DI
- 69448351ENDO02NS34 EUDAMED
- Direct Marketing DI
- 06944835190281 EUDAMED
- FDA Product Code
- DZP FDA UDI
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4535 FDA UDI
- Market of Registration
- Ireland 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Root Canal Files by Shenzhen Superline Technology 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 | 69448351ENDO02NS34 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Superline Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027059
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (3)
- EUDAMED 5c0cadd1-97d8-4d2a-9792-6eb7bb0ad352 61 fields · synced Jun 18, 2026
- FDA UDI cd921f93-8303-46db-a870-10facd9f814f 34 fields · synced May 30, 2026
- EUDAMED 5c0cadd1-97d8-4d2a-9792-6eb7bb0ad352-1 61 fields · synced Jun 10, 2026