GUDIDData
gudid Primary ID: 00046501202A

Dentek (UDI 00046501202A)

Manufactured by DenTek Oral Care, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Dentek - Primary ID 00046501202A

Device Regulatory Overview

The Dentek (Model/Catalog Number: 00046501202A) is a medical device manufactured by DenTek Oral Care, Inc.. This product is indexed under FDA Product Code / Category Classification OBR within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
00046501202A
Product Code / EMDN
OBR
Device Name
DNTK READY FIT 16CT DNTL GRD 12
Database Sync Date
2026-08-09 09:08:49

Full Regulatory Attributes

🔒 Token Gated
{
    "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 Dentek?

The registered manufacturer of record for Dentek is DenTek Oral Care, Inc..

What is the Primary UDI-DI identifier for Dentek?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00046501202A.

What classification code is assigned to this device?

This device is registered under product classification code OBR.

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