LuxCreo DentalNight Guard Resin

FDA UDI

Class U (US FDA UDI)

by LuxCreo, Inc.

Identity

Trade Name: LuxCreo DentalNight Guard Resin FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: Product Name:LuxCreo DentalNight Guard Resin;ModelNumbers:5kg/Bottle,K230592 FDA UDI
Model / Reference: 5kg/Bottle FDA UDI
Description: Product Name:LuxCreo DentalNight Guard Resin;ModelNumbers:5kg/Bottle,K230592 FDA UDI

Identifiers

Primary DI / UDI-DI: 00860010425497 FDA UDI
510(k) Number: K230592 FDA UDI
FDA Product Code: MQC FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, resin

LuxCreo DentalNight Guard Resin by LuxCreo, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K230592 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: LuxCreo, Inc.

Sources (1)

FDA UDI c91326a5-4607-467a-9f07-b5d2e80edae6 34 fields · synced May 30, 2026