Identity
- Trade Name
- File-Eze FDA UDI
- Generic Name
- Endodontic reaming aid material FDA UDI
- Device Name
- File-Eze IndiSpense Refill FDA UDI
- Model / Reference
- 682 FDA UDI
- Description
- File-Eze IndiSpense Refill FDA UDI
Identifiers
- Catalog Number
- 682 FDA UDI
- Primary DI / UDI-DI
- 00883205105875 FDA UDI
- 510(k) Number
- K060335 FDA UDI
- FDA Product Code
- KJI FDA UDI
- GMDN Term
- Endodontic reaming aid material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3520 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic reaming aid material
File-Eze by Ultradent Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K060335 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
Sources (1)
- FDA UDI 332f3499-e45f-4f94-8c82-9d8352139a2c 37 fields · synced Jun 8, 2026