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H-Files
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref HEDSTROM FILES 31mm #30 / SS503-306
Identity
- Trade Name
- ENDODONTIC STAINLESS STEEL HAND FILES EUDAMEDH-FILES FDA UDI
- Generic Name
- Manual endodontic file/rasp, reusable FDA UDI
- Device Name
- ENDODONTIC INSTRUMENTS EUDAMEDFiles are mainly used to the preparation for various of dental pulp inflammation and dead dental pulp root canal treatment. FDA UDI
- Model / Reference
- HEDSTROM FILES 31mm #30 / SS503-306 EUDAMED31m/m 30 FDA UDI
- Description
- Files are mainly used to the preparation for various of dental pulp inflammation and dead dental pulp root canal treatment. FDA UDI
Identifiers
- Catalog Number
- SS503-306 FDA UDI
- Primary DI / UDI-DI
- 08806383537537 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual endodontic file/rasp, reusable
H-Files 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
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- 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
European Union Unknown
MDR
United States Pending data
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 f2fcaf8f-e7d9-48dd-9762-1b42811a23c9 34 fields · synced Jun 19, 2026
- EUDAMED e655acf3-abba-487b-9ec4-b53c3a0e3fc1 61 fields · synced Jun 19, 2026