GUDIDData
gudid Primary ID: 171250

LuxaPrint Ortho Flex 385 (UDI 171250)

Manufactured by DMG Digital Enterprises SE

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for LuxaPrint Ortho Flex 385 - Primary ID 171250

Device Regulatory Overview

The LuxaPrint Ortho Flex 385 (Model/Catalog Number: 171250) is a medical device manufactured by DMG Digital Enterprises SE. This product is indexed under FDA Product Code / Category Classification QJJ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
171250
Product Code / EMDN
QJJ
Device Name
(Meth) acrylate-based light-curing resin for the fabrication of bleaching trays and transfer trays (in case of indirect bonding of brackets) using 3D printing. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Shade: Transparent, Content: 1 Bottle @ 500 g
Database Sync Date
2026-08-09 09:01:10

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 LuxaPrint Ortho Flex 385?

The registered manufacturer of record for LuxaPrint Ortho Flex 385 is DMG Digital Enterprises SE.

What is the Primary UDI-DI identifier for LuxaPrint Ortho Flex 385?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 171250.

What classification code is assigned to this device?

This device is registered under product classification code QJJ.

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