FDA.reportPublic FDA data

LuxaPrint Ortho 385

Primary DI
D9821712560
Brand
LuxaPrint Ortho 385
Company
DMG Digital Enterprises SE
Model
171256
Catalog number
171256
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 @ 200 g
Published
2022-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYTMaintainer, Space Preformed, Orthodontic
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYTMaintainer, Space Preformed, OrthodonticDental1
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9821712561PackageHIBCC1In Commercial Distribution
D9821712560PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA 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
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place and protected from light! Always keep the container tightly sealed. Carefully seal immediately after every use.
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
201-894-5505ccosta@dmg-america.com

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 DIBrandModelCatalogPublished
D9821716301LuxaPrint Ortho Plus NX 385 nm1716302026-07-21
D9821716311LuxaPrint Ortho Plus NX 385 nm1716312026-07-21
D9821716321LuxaPrint Ortho Plus NX 385 nm1716322026-07-21
D9821716331LuxaPrint Ortho Plus NX 385 nm1716332026-07-21
D9821716341LuxaPrint Ortho Plus NX 385 nm1716342026-07-21
D9821716351LuxaPrint Ortho Plus NX 405 nm1716352026-07-21
D9821716361LuxaPrint Ortho Plus NX 405 nm1716362026-07-21
D9821716371LuxaPrint Ortho Plus NX 405 nm1716372026-07-21
D9821716201LuxaPrint Ortho NX 385 nm1716201716202026-05-26
D9821716211LuxaPrint Ortho NX 385 nm1716211716212026-05-26
D9821716221LuxaPrint Ortho NX 385 nm1716221716222026-05-26
D9821716231LuxaPrint Ortho NX 385 nm1716231716232026-05-26
D9821716241LuxaPrint Ortho NX 385 nm1716241716242026-05-26
D9821716251LuxaPrint Ortho NX 405 nm1716251716252026-05-26
D9821716261LuxaPrint Ortho NX 405 nm1716261716262026-05-26
D9821716271LuxaPrint Ortho NX 405 nm1716271716272026-05-26
D9821716150LuxaPrint Ortho Flex NX1716151716152026-05-06
D9821716170LuxaPrint Ortho Flex NX1716171716172026-05-06
D9821716180LuxaPrint Ortho Flex NX1716181716182026-05-06
D9821716190LuxaPrint Ortho Flex NX1716191716192026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
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07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14