Paradigm Quantum PBX-PR-H25

GUDID D948PBXPRH250

.07v taper NiTi reciprocating endodontic file, size primary, 25mm length, heat treated

Smarter Alloys Inc

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: D948PBXPRH250
• NIH Device Record Key: 042e6c4f-4b6b-4155-a7a5-c76f979edd17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paradigm Quantum
• Version Model Number: PRHT
• Catalog Number: PBX-PR-H25
• 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	D948PBXPRH250 [Unit of Use]
HIBCC	D948PBXPRH251 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

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

[D948PBXPRH250]

Moist Heat or Steam Sterilization

[D948PBXPRH250]

Moist Heat or Steam Sterilization

[D948PBXPRH250]

Moist Heat or Steam Sterilization

[D948PBXPRH250]

Moist Heat or Steam Sterilization

[D948PBXPRH250]

Moist Heat or Steam Sterilization

[D948PBXPRH250]

Moist Heat or Steam Sterilization

[D948PBXPRH250]

Moist Heat or Steam Sterilization

[D948PBXPRH250]

Moist Heat or Steam Sterilization

[D948PBXPRH250]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-02
• Device Publish Date: 2021-08-25

On-Brand Devices [Paradigm Quantum]

• D948PBXSMH250: .07v taper NiTi reciprocating endodontic file, size small, 25mm length, heat treated
• D948PBXPRH250: .07v taper NiTi reciprocating endodontic file, size primary, 25mm length, heat treated
• D948PBXMDH250: .06v taper NiTi reciprocating endodontic file, size medium, 25mm length, heat treated
• D948PBXLGH250: .05v taper NiTi reciprocating endodontic file, size large, 25mm length, heat treated