Home GUDID D9821712090
LuxaPrint Ortho 405
Primary DI D9821712090
Brand LuxaPrint Ortho 405
Company DMG Digital Enterprises SE
Model 171209
Catalog number 171209
Device description (Meth) acrylate-based light-curing resin for the fabrication of surgical guides and splints. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Content: 1 Bottle @ 1 kg
Published 2022-09-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name DYT Maintainer, Space Preformed, Orthodontic NDP Accessories, Implant, Dental, Endosseous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYT Maintainer, Space Preformed, Orthodontic Dental 1 NDP Accessories, Implant, Dental, Endosseous Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D9821712091 Package HIBCC 1 In Commercial Distribution D9821712090 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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use. Storage Environment Temperature 15 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 59 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 342962296 Device count 1 Premarket exempt true Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 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 D9821712070 LuxaPrint Ortho 385 171207 171207 2022-09-01 D9821712080 LuxaPrint Ortho 405 171208 171208 2022-09-01 D9821712500 LuxaPrint Ortho Flex 385 171250 171250 2022-09-01 D9821712510 LuxaPrint Ortho Flex 385 171251 171251 2022-09-01 D9821712520 LuxaPrint Ortho Flex 385 171252 171252 2022-09-01 D9821712530 LuxaPrint Ortho Flex 385 171253 171253 2022-09-01 D9821712560 LuxaPrint Ortho 385 171256 171256 2022-09-01
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