FDA.report

LuxCreo DentalNight Guard Resin

Primary DI
00860010425473
Brand
LuxCreo DentalNight Guard Resin
Company
Luxcreo Inc
Model
0.5kg/Bottle
Device description
Product Name:LuxCreo DentalNight Guard Resin;ModelNumbers:0.5kg/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

Related Records

Product Codes

CodeName
MQCMouthguard, Prescription

Product Code Classifications

CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions

SubmissionSupplement
K230592000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860010425473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010425473008600104254738600104254730860010425473

GMDN Terms

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

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 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
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

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