FDA.reportPublic FDA data

LuxCreo Dental Night Guard Resin

Primary DI
00860010425411
Brand
LuxCreo Dental Night Guard Resin
Company
Luxcreo Inc
Model
0.5kg/Bottle
Device description
LuxCreo Dental Night Guard Resin is a liquid light-curing resin product indicated for the Three-Dimensional fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, and repositioners.
Published
2023-07-31
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
EEAPlate, Base, Shellac

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEAPlate, Base, ShellacDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010425411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010425411008600104254118600104254110860010425411

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8613738495712hanyu.xiang@luxcreo.ai

Regulatory Flags#

DUNS number
117470150
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013903121LuxCreoModel: Clear ;Specifications 0.5kg/bottle2025-12-11
00860013903138LuxCreoModel: Clear ;Specifications 1kg/bottle2025-12-11
00860013903107LuxCreo Clear Aligner SystemDCA-TB2025-04-18
00860013903114LuxCreo Clear Aligner SystemDCA-TC2025-04-18
00860010425404LuxCreo Clear Aligner SystemDCA-TB2024-04-09
00860010425466LuxCreo Clear Aligner SystemDCA-TC2024-04-09
00860010425473LuxCreo DentalNight Guard Resin0.5kg/Bottle2024-04-09
00860010425480LuxCreo DentalNight Guard Resin1kg/Bottle2024-04-09
00860010425497LuxCreo DentalNight Guard Resin5kg/Bottle2024-04-09
00860010425428LuxCreo Dental Night Guard Resin1kg/Bottle2023-07-31
00860010425435LuxCreo Dental Night Guard Resin5kg/Bottle2023-07-31
00860010425442LuxCreo Dental Clear Aligner Resin0.5kg/Bottle2023-07-31
00860010425459LuxCreo Dental Clear Aligner Resin1kg/Bottle2023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412328068Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328075Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328082Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328099Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328105Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
E239D359501FotoDent® TryInDreve Dentamid GmbHEEA2026-02-27
04260635981594RS VIVO Try-InDeltaMed GmbHEEA2025-07-29
EDEL162112103Delta Try-In XTDeltaMed GmbHEEA2025-07-29
EPRC0220003ACRY PRINT RU-003 Try-Inpro3dure medical GmbHEEA2025-03-31
EPRC768485UCAN Print Try-Inpro3dure medical GmbHEEA2025-03-31
D161280200Axio-BaseAxiodent Inc.EEA2024-10-02
08720604633832Vertex-Dental BVVertex-Dental B.V.EEA2024-04-19
08720604633849Vertex-Dental BVVertex-Dental B.V.EEA2024-04-19
08720604633856Vertex-Dental BVVertex-Dental B.V.EEA2024-04-19
D040711820Veri DENT TryinWHIP-MIX CORPORATIONEEA2024-04-18
EPRCD1001651printodent GR-21.1 Try-In pro3dure medical GmbHEEA2023-10-16
EPRCD1001652printodent GR-21.1 Try-In pro3dure medical GmbHEEA2023-10-16
EPRCD1001653printodent GR-21.1 Try-In pro3dure medical GmbHEEA2023-10-16
00860010425428LuxCreo Dental Night Guard ResinLuxcreo IncEEA2023-07-31
00860010425435LuxCreo Dental Night Guard ResinLuxcreo IncEEA2023-07-31
D967130010Hiflex Base PlatesPREVEST DENPRO LIMITEDEEA2022-12-19
EPRCD1001602PRO3DURE GR-21 Try-In pro3dure medical GmbHEEA2022-09-12
EPRCD1001603PRO3DURE GR-21 Try-In pro3dure medical GmbHEEA2022-09-12
EPRCD1001601PRO3DURE GR-21 Try-In pro3dure medical GmbHEEA2022-08-17
10850039704151Try-In 2Sprintray, Inc.EEA2022-02-28
04260635980207P pro Try-InDeltaMed GmbHEEA2022-02-11
04260635980542RS Try-InDeltaMed GmbHEEA2022-02-11
EDEL162111003Delta Try-InDeltaMed GmbHEEA2022-02-11
EDEL162112003Delta Try-InDeltaMed GmbHEEA2022-01-31
E22160491V-Print Try-InVOCO GmbHEEA2020-06-16