REAMERS (Nickel-Titanium)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- ENDODONTIC NI-TI HAND FILES EUDAMEDREAMERS (Nickel-Titanium) FDA UDI
- Generic Name
- Manual endodontic file/rasp, reusable FDA UDI
- Device Name
- ENDODONTIC INSTRUMENTS EUDAMEDREAMERS are mainly used to the preparation for various of dental pulp inflammation and dead dental pulp root canal treatment. FDA UDI
- Model / Reference
- REAMERS 25mm #30 / NT501-206 EUDAMED25m/m 30 FDA UDI
- Description
- REAMERS are mainly used to the preparation for various of dental pulp inflammation and dead dental pulp root canal treatment. FDA UDI
Identifiers
- Catalog Number
- NT501-206 FDA UDI
- Primary DI / UDI-DI
- 08806383532280 EUDAMEDFDA UDI
- Basic UDI-DI
- 88063835EIF3J EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
- GMDN Term
- Manual endodontic file/rasp, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Manual endodontic file/rasp, reusable
REAMERS (Nickel-Titanium) by DiaDent Group International — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual endodontic file/rasp, reusable.
- K-Files 21mm 070, pu: 6 pcs — Diaswiss SA · Class I
- K-Files — MICRO MEGA · Class I
- Hand instrument K-file — TULSA DENTAL PRODUCTS LLC · Class I
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- ProFile .04 Taper Hand File — TULSA DENTAL PRODUCTS LLC · Class I
- KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- SafeSiders — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DiaDent Group International
Sources (2)
- FDA UDI ee1c6420-f185-4385-80ca-2250a0dc4347 34 fields · synced Jul 19, 2026
- EUDAMED 383f308f-343d-4dbc-b7fd-77562dcd7a73 61 fields · synced Jul 19, 2026