FDA.reportPublic FDA data

LuxCreo DentalNight Guard Resin

Primary DI
00860010425480
Brand
LuxCreo DentalNight Guard Resin
Company
Luxcreo Inc
Model
1kg/Bottle
Device description
Product Name:LuxCreo DentalNight Guard Resin;ModelNumbers:1kg/Bottle,K230592
Published
2024-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230592000LuxCreo Dental Night Guard ResinLuxCreo, Inc.2024-01-18MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010425480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010425480008600104254808600104254800860010425480

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117470150
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
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
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
00860013500733Custom Night GuardGrindGuard Inc.MQC2026-03-05
00860013500740Custom Night GuardGrindGuard Inc.MQC2026-03-05
00860014754609Owl Night GuardOWL DENTAL LAB INCMQC2026-03-05
00860014754616Owl Night GuardOWL DENTAL LAB INCMQC2026-03-05
00860014754623Owl Night GuardOWL DENTAL LAB INCMQC2026-03-05
00860015217738enCore Night GuardENCORE LABORATORY LLCMQC2026-03-02
E4947610871Ceramill A-SplintAmann Girrbach AGMQC2026-01-21
E4947610881Ceramill A-SplintAmann Girrbach AGMQC2026-01-21
E4947610891Ceramill A-SplintAmann Girrbach AGMQC2026-01-21
00860015217707enCore Night GuardENCORE LABORATORY LLCMQC2026-01-08
D7091019275M-PM DiscMerz Dental GmbHMQC2026-01-01
00860007686627Slow WaveSlow Wave, Inc.MQC2025-09-24
00850073333013Night Guard 3D DIAGNOSTIX, INC.MQC2025-09-11
D040711830VeriFIT SplintWHIP-MIX CORPORATIONMQC2025-09-04
10190730084580Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
10190730084597Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
00860461001790Reva Thermoforming Sheet MaterialUlab Systems, Inc.MQC2025-04-29
EPRC0220005ACRY PRINT RU-005 Guidepro3dure medical GmbHMQC2025-03-31
EPRC768486UCAN Print Splintpro3dure medical GmbHMQC2025-03-31
00860013500702Custom Night GuardGrindGuard Inc.MQC2025-03-17
D805500301BCUSTOMX100iFlex by TCSTHERMOPLASTIC COMFORT SYSMQC2025-01-22
00304040188200Henry ScheinHENRY SCHEIN, INC.MQC2024-11-12
00304040188217Henry ScheinHENRY SCHEIN, INC.MQC2024-11-12
07540204000077Panthera Occlusal Appliance - SinglePanthera Dentaire IncMQC2024-10-28
EPRCD1000808printodent GR-10 guide I MSI pro3dure medical GmbHMQC2024-08-20
00860005753086Nylon Nightguard/Occlusal ApplianceSERENA SLEEP SOLUTIONS LLCMQC2024-06-05
00850061175106Dental LT Comfort ResinFORMLABS OHIO INC.MQC2024-04-24
00860010425473LuxCreo DentalNight Guard ResinLuxcreo IncMQC2024-04-09
00860010425497LuxCreo DentalNight Guard ResinLuxcreo IncMQC2024-04-09
D805500301B1X10iFlex by TCSTHERMOPLASTIC COMFORT SYSMQC2024-03-11