gudid Primary ID: 70-BIO-DWD10

Newport Biologics Resorbable Collagen Plug (UDI 70-BIO-DWD10)

Manufactured by Prismatik Dentalcraft, Inc

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Newport Biologics Resorbable Collagen Plug (Model/Catalog Number: 70-BIO-DWD10) is a medical device manufactured by Prismatik Dentalcraft, Inc. This product is indexed under FDA Product Code / Category Classification KGN 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-BIO-DWD10
Product Code / EMDN: KGN
Device Name: Resorbable Collagen Plug (10 per box)
Database Sync Date: 2026-08-09 09:14:59

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 Newport Biologics Resorbable Collagen Plug?

The registered manufacturer of record for Newport Biologics Resorbable Collagen Plug is Prismatik Dentalcraft, Inc.

What is the Primary UDI-DI identifier for Newport Biologics Resorbable Collagen Plug?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 70-BIO-DWD10.

What classification code is assigned to this device?

This device is registered under product classification code KGN.

Similar Classification Devices (KGN)

Other Devices by Prismatik Dentalcraft, Inc

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