FDA.reportPublic FDA data

LuxCreo

Primary DI
00860013903121
Brand
LuxCreo
Company
Luxcreo Inc
Model
Model: Clear ;Specifications 0.5kg/bottle
Device description
LuxCreo Flexible Partial Denture (FPD) Resin is a state of the art resin engineered specifically for the 3D Printing of digitally designed flexible partial denture bases. The FPD resin utilizes LuxCreo’s Digital Polishing platform to deliver clear, accurate, and biocompatible partial dentures in a single session with minimal need for finishing.
Published
2025-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253365000LuxCreo Flexible Partial Denture ResinLuxCreo, Inc.2025-11-25EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013903121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013903121008600139031218600139031210860013903121

GMDN Terms#

Term, Definition table
TermDefinition
Denture base resin kitA collection of resins and other devices and/or materials intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually includes the resin monomer (e.g., acrylic monomer of methyl methacrylate), a catalyst intended for polymerization, and additional products such as pigments, plasticizers, and/or devices (e.g., flasks, clamps). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117470150
Device count
1
DM 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
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
00860010425411LuxCreo Dental Night Guard Resin0.5kg/Bottle2023-07-31
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
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06942480721454FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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06942480722284FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722291FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722505FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722512FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723335FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723342FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
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00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
08056640078321major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078338major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078345major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078352major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30