FDA.reportPublic FDA data

LuxaPrint Ortho 385

Primary DI
D9821712070
Brand
LuxaPrint Ortho 385
Company
DMG Digital Enterprises SE
Model
171207
Catalog number
171207
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

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
D9821712071PackageHIBCC1In Commercial Distribution
D9821712070PrimaryHIBCC0

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
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
D9821716160LuxaPrint Ortho Flex NX1716161716162026-05-06
D9821712080LuxaPrint Ortho 4051712081712082022-09-01
D9821712090LuxaPrint Ortho 4051712091712092022-09-01
D9821712500LuxaPrint Ortho Flex 3851712501712502022-09-01
D9821712510LuxaPrint Ortho Flex 3851712511712512022-09-01
D9821712520LuxaPrint Ortho Flex 3851712521712522022-09-01
D9821712530LuxaPrint Ortho Flex 3851712531712532022-09-01
D9821712560LuxaPrint Ortho 3851712561712562022-09-01

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