Home GUDID D9821716311
LuxaPrint Ortho Plus NX 385 nm
Primary DI D9821716311
Brand LuxaPrint Ortho Plus NX 385 nm
Company DMG Digital Enterprises SE
Model 171631
Device description Light-curing resin based on (meth)acrylate for the production of dental devices. For DLP/ SLA printers that work at wavelengths of 385 nm and 405 nm. Content: 1 Bottle @ 500 g
Published 2026-07-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name MQC Mouthguard, Prescription
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MQC Mouthguard, Prescription Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D9821716311 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental appliance fabrication material, resin A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.
Regulatory Flags# DUNS number 342962296 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D9821716301 LuxaPrint Ortho Plus NX 385 nm 171630 2026-07-21 D9821716321 LuxaPrint Ortho Plus NX 385 nm 171632 2026-07-21 D9821716331 LuxaPrint Ortho Plus NX 385 nm 171633 2026-07-21 D9821716341 LuxaPrint Ortho Plus NX 385 nm 171634 2026-07-21 D9821716351 LuxaPrint Ortho Plus NX 405 nm 171635 2026-07-21 D9821716361 LuxaPrint Ortho Plus NX 405 nm 171636 2026-07-21 D9821716371 LuxaPrint Ortho Plus NX 405 nm 171637 2026-07-21 D9821716201 LuxaPrint Ortho NX 385 nm 171620 171620 2026-05-26 D9821716211 LuxaPrint Ortho NX 385 nm 171621 171621 2026-05-26 D9821716221 LuxaPrint Ortho NX 385 nm 171622 171622 2026-05-26 D9821716231 LuxaPrint Ortho NX 385 nm 171623 171623 2026-05-26 D9821716241 LuxaPrint Ortho NX 385 nm 171624 171624 2026-05-26 D9821716251 LuxaPrint Ortho NX 405 nm 171625 171625 2026-05-26 D9821716261 LuxaPrint Ortho NX 405 nm 171626 171626 2026-05-26 D9821716271 LuxaPrint Ortho NX 405 nm 171627 171627 2026-05-26 D9821716150 LuxaPrint Ortho Flex NX 171615 171615 2026-05-06 D9821716170 LuxaPrint Ortho Flex NX 171617 171617 2026-05-06 D9821716180 LuxaPrint Ortho Flex NX 171618 171618 2026-05-06 D9821716190 LuxaPrint Ortho Flex NX 171619 171619 2026-05-06 D9821716160 LuxaPrint Ortho Flex NX 171616 171616 2026-05-06
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