gudid Primary ID: 70-1182-NOW0075

BruxZir (UDI 70-1182-NOW0075)

Manufactured by Prismatik Dentalcraft, Inc

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

Scannable UDI-DI Representation

Device Regulatory Overview

The BruxZir (Model/Catalog Number: 70-1182-NOW0075) is a medical device manufactured by Prismatik Dentalcraft, Inc. This product is indexed under FDA Product Code / Category Classification EIH within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2897-2016 View Full Alert →

BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for...

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Technical Specifications

Model Number: 70-1182-NOW0075
Product Code / EMDN: EIH
Device Name: BruxZir Esthetic NOW Posterior Block - D3
Database Sync Date: 2026-08-09 09:03:00

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 BruxZir?

The registered manufacturer of record for BruxZir is Prismatik Dentalcraft, Inc.

What is the Primary UDI-DI identifier for BruxZir?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 70-1182-NOW0075.

What classification code is assigned to this device?

This device is registered under product classification code EIH.

Similar Classification Devices (EIH)

Other Devices by Prismatik Dentalcraft, Inc

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