Paradigm BX PBX-M1-N25

GUDID D948PBXM1N250

Multi-taper NiTi rotary endodontic file, size M1, 25mm length

Smarter Alloys Inc

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: D948PBXM1N250
• NIH Device Record Key: 6be7489b-3a47-4dbd-9000-ae15cb19ed1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paradigm BX
• Version Model Number: M1
• Catalog Number: PBX-M1-N25
• Company DUNS: 200106716
• Company Name: Smarter Alloys Inc
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D948PBXM1N250 [Unit of Use]
HIBCC	D948PBXM1N251 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D948PBXM1N250]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-29
• Device Publish Date: 2020-05-21

On-Brand Devices [Paradigm BX]

• D948PBXM5N250: Multi-taper NiTi rotary endodontic file, size M5, 25mm length
• D948PBXM4N250: Multi-taper NiTi rotary endodontic file, size M4, 25mm length
• D948PBXM3N250: Multi-taper NiTi rotary endodontic file, size M3, 25mm length
• D948PBXM2N250: Multi-taper NiTi rotary endodontic file, size M2, 25mm length
• D948PBXM1N250: Multi-taper NiTi rotary endodontic file, size M1, 25mm length
• D948PBXAXN190: Multi-taper NiTi rotary endodontic file, size AX, 19mm length
• D948PBXASN250: Multi-taper NiTi rotary endodontic file, assorted pack, sizes AX-M3, 19-25mm length
• D948PBXA2N250: Multi-taper NiTi rotary endodontic file, size A2, 25mm length
• D948PBXA1N250: Multi-taper NiTi rotary endodontic file, size A1, 25mm length