gudid Primary ID: PR

Paradigm Quantum (UDI PR)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Paradigm Quantum (Model/Catalog Number: PR) is a medical device manufactured by Smarter Alloys Inc. This product is indexed under FDA Product Code / Category Classification EKS within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: PR
Product Code / EMDN: EKS
Device Name: .07v taper NiTi reciprocating endodontic file, size primary, 25mm length
Database Sync Date: 2026-08-09 09:01:11

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Paradigm Quantum?

The registered manufacturer of record for Paradigm Quantum is Smarter Alloys Inc.

What is the Primary UDI-DI identifier for Paradigm Quantum?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is PR.

What classification code is assigned to this device?

This device is registered under product classification code EKS.

Similar Classification Devices (EKS)

Other Devices by Smarter Alloys Inc

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