FDA.reportPublic FDA data

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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9821716311PrimaryHIBCC0

Contacts#

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

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 DIBrandModelCatalogPublished
D9821716301LuxaPrint Ortho Plus NX 385 nm1716302026-07-21
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
D9821716160LuxaPrint Ortho Flex NX1716161716162026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412314672Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314689Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314696Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314702Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314719Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314726Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314733Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314740Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314757Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314764Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314771Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314788Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314795Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314801Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314818Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
D9821716301LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716321LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716331LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716341LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716351LuxaPrint Ortho Plus NX 405 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716361LuxaPrint Ortho Plus NX 405 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716371LuxaPrint Ortho Plus NX 405 nmDMG Digital Enterprises SEMQC2026-07-21
04260670160510dentona flexisplintdentona AGMQC2026-06-23
04260670160527dentona flexisplintdentona AGMQC2026-06-23
04260670160534dentona flexisplintdentona AGMQC2026-06-23
04260670160541dentona flexisplintdentona AGMQC2026-06-23
04260670160558dentona flexisplintdentona AGMQC2026-06-23
04260670160572dentona flexisplintdentona AGMQC2026-06-23
04260670160589dentona flexisplintdentona AGMQC2026-06-23
04260670160596dentona vivatempdentona AGMQC2026-06-23