LuxCreo Clear Aligner System

FDA UDI

Class II (US FDA UDI)

by LuxCreo, Inc.

Identity

Trade Name: LuxCreo Clear Aligner System FDA UDI
Generic Name: Orthodontic space maintainer FDA UDI
Device Name: Product Name:LuxCreo Clear Aligner System;Model:Clear;Specification:DCA-TB;K250343. FDA UDI
Model / Reference: DCA-TB FDA UDI
Description: Product Name:LuxCreo Clear Aligner System;Model:Clear;Specification:DCA-TB;K250343. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860013903107 FDA UDI
510(k) Number: K250343 FDA UDI
FDA Product Code: NXC FDA UDI
GMDN Term: Orthodontic space maintainer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5470 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

Yes

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: Orthodontic space maintainer

LuxCreo Clear Aligner System by LuxCreo, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K250343 also covers:

LuxCreo Clear Aligner System — LuxCreo, Inc.

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 II	Pending data

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Manufacturer

Manufacturer: LuxCreo, Inc.

Sources (1)

FDA UDI e99821b5-988c-42f4-bd2a-4a9dbc805699 34 fields · synced May 30, 2026