Identity
- Trade Name
- HEDSTROM FILES FDA UDI
- Generic Name
- Manual endodontic file/rasp, reusable FDA UDI
- Device Name
- Files are mainly used to the preparation for various of dental pulp inflammation and dead dental pulp root canal treatment. FDA UDI
- Model / Reference
- 21m/m 60 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
- 503-112 FDA UDI
- Primary DI / UDI-DI
- 08806383519861 FDA UDI
- FDA Product Code
- EKS FDA UDI
- GMDN Term
- Manual endodontic file/rasp, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Hedstrom Files by DiaDent Group International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Manual endodontic file/rasp, reusable.
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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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DiaDent Group International
Sources (1)
- FDA UDI 85a3a088-6668-4090-bf8d-d53ca127d0a3 34 fields · synced May 31, 2026