Identity
- Trade Name
- Paradigm BX FDA UDI
- Generic Name
- Rotary/reciprocating endodontic file/rasp, single-use FDA UDI
- Device Name
- Multi-taper NiTi rotary endodontic file, size M5, 25mm length FDA UDI
- Model / Reference
- M5 FDA UDI
- Description
- Multi-taper NiTi rotary endodontic file, size M5, 25mm length FDA UDI
Identifiers
- Catalog Number
- PBX-M5-N25 FDA UDI
- Primary DI / UDI-DI
- D948PBXM5N251 FDA UDI
- FDA Product Code
- EKS FDA UDI
- GMDN Term
- Rotary/reciprocating endodontic file/rasp, single-use 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
Yes
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: Rotary/reciprocating endodontic file/rasp, single-use
Paradigm BX by Smarter Alloys Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rotary/reciprocating endodontic file/rasp, single-use.
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- VaryFlex Reciprocating, VFRF 50, 25mm — ENDOPERFECTION LIMITED · 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
- Smarter Alloys Inc
Sources (1)
- FDA UDI 1cfc1ef3-b8e2-4263-8128-1d8c77c21aea 34 fields · synced May 31, 2026