FDA.reportPublic FDA data

LuxaPrint Tray

Primary DI
D9821712660
Brand
LuxaPrint Tray
Company
DMG Digital Enterprises SE
Model
171266
Catalog number
171266
Device description
(Meth) acrylate-based light-curing resin for the fabrication of custom impression trays. 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
EBHMaterial, Impression Tray, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9821712661PackageHIBCC1In Commercial Distribution
D9821712660PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray materialA material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.

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
D14307560147448590Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBH2026-07-23
00840456224427JMUJMU DENTAL, INCEBH2026-07-20
00840456224434JMUJMU DENTAL, INCEBH2026-07-20
00840456206942JMUJMU DENTAL, INCEBH2026-07-09
00840456207024JMUJMU DENTAL, INCEBH2026-07-09
00840456207031JMUJMU DENTAL, INCEBH2026-07-09
00840456207048JMUJMU DENTAL, INCEBH2026-07-09
00840456207055JMUJMU DENTAL, INCEBH2026-07-09
00840456207062JMUJMU DENTAL, INCEBH2026-07-09
00840456207079JMUJMU DENTAL, INCEBH2026-07-09
00840456207086JMUJMU DENTAL, INCEBH2026-07-09
00840456207093JMUJMU DENTAL, INCEBH2026-07-09
00840456207109JMUJMU DENTAL, INCEBH2026-07-09
00840456209332JMUJMU DENTAL, INCEBH2026-07-09
00840456209349JMUJMU DENTAL, INCEBH2026-07-09
00840456209356JMUJMU DENTAL, INCEBH2026-07-09
00840456214138JMUJMU DENTAL, INCEBH2026-07-09
00840456214145JMUJMU DENTAL, INCEBH2026-07-09
00840456214152JMUJMU DENTAL, INCEBH2026-07-09
00840456214169JMUJMU DENTAL, INCEBH2026-07-09
00840456214176JMUJMU DENTAL, INCEBH2026-07-09
00840456214183JMUJMU DENTAL, INCEBH2026-07-09
00840456214190JMUJMU DENTAL, INCEBH2026-07-09
00840456214206JMUJMU DENTAL, INCEBH2026-07-09
00840456214213JMUJMU DENTAL, INCEBH2026-07-09
00840456214220JMUJMU DENTAL, INCEBH2026-07-09
00840456223680JMUJMU DENTAL, INCEBH2026-07-09
00840456223697JMUJMU DENTAL, INCEBH2026-07-09
00840456223703JMUJMU DENTAL, INCEBH2026-07-09
00840456223710JMUJMU DENTAL, INCEBH2026-07-09