Identity
- Trade Name
- Henry Schein EUDAMEDFDA UDI
- Generic Name
- Manual endodontic file/rasp, reusable FDA UDI
- Device Name
- Rotary NiTi file U Coro CX orange 19mm EUDAMEDEndoflex Hedstrom Files 25 mm FDA UDI
- Model / Reference
- 5701864 EUDAMEDFDA UDITF-123 EUDAMED
- Description
- Endoflex Hedstrom Files 25 mm FDA UDI
Identifiers
- Catalog Number
- 5701864 FDA UDI
- Primary DI / UDI-DI
- 10304040127053 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10304040127053 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- Q010407 ORTHODONTIC CEMENTS EUDAMED
- GMDN Term
- Manual endodontic file/rasp, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Manual endodontic file/rasp, reusable
Henry Schein by Henry Schein, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual endodontic file/rasp, reusable.
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- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- 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
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
- Henry Schein, Inc.
Sources (2)
- FDA UDI c6dab615-299e-4391-ae28-eb14b3e9c33c 34 fields · synced Oct 5, 2026
- EUDAMED 1930a617-6954-490a-89ef-e8ea98bea9d9 61 fields · synced Oct 5, 2026