gudid Primary ID: 1640-00

BIOSEAL (UDI 1640-00)

Manufactured by ESSENTIAL DENTAL SYSTEMS, INC.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The BIOSEAL (Model/Catalog Number: 1640-00) is a medical device manufactured by ESSENTIAL DENTAL SYSTEMS, INC.. This product is indexed under FDA Product Code / Category Classification KIF within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 1640-00
Product Code / EMDN: KIF
Device Name: Bioceramic Endodontic Sealer
Database Sync Date: 2026-08-09 09:41:29

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 BIOSEAL?

The registered manufacturer of record for BIOSEAL is ESSENTIAL DENTAL SYSTEMS, INC..

What is the Primary UDI-DI identifier for BIOSEAL?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1640-00.

What classification code is assigned to this device?

This device is registered under product classification code KIF.

Similar Classification Devices (KIF)

Other Devices by ESSENTIAL DENTAL SYSTEMS, INC.

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