gudid Primary ID: Extra Large

Bioclear Diamond Wedge (UDI Extra Large)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Bioclear Diamond Wedge (Model/Catalog Number: Extra Large) is a medical device manufactured by Bioclear Matrix Systems. This product is indexed under FDA Product Code / Category Classification EJB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Extra Large
Product Code / EMDN: EJB
Device Name: Plastic wedge used in dental restorations.
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 Bioclear Diamond Wedge?

The registered manufacturer of record for Bioclear Diamond Wedge is Bioclear Matrix Systems.

What is the Primary UDI-DI identifier for Bioclear Diamond Wedge?

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

What classification code is assigned to this device?

This device is registered under product classification code EJB.

Similar Classification Devices (EJB)

Other Devices by Bioclear Matrix Systems

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