LuxCreo Clear Aligner System

Basic Information

• Brand Name: LuxCreo Clear Aligner System
• Primary DI: 00860013903107
• Version / Model: DCA-TB
• Company Name: Luxcreo Inc
• Labeler DUNS: 117470150
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-18
• Public Version: 1
• Public Version Date: 2025-04-28
• Public Version Status: New
• Public Device Record Key: e99821b5-988c-42f4-bd2a-4a9dbc805699

Device Description

Product Name:LuxCreo Clear Aligner System;Model:Clear;Specification:DCA-TB;K250343.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NXC	Aligner, Sequential	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31754	Orthodontic space maintainer	A dental prosthetic replacement for prematurely lost deciduous teeth intended to prevent closure of the space before eruption of the permanent successors. It is often an urgent necessity in the buccal segment to prevent impaction of the permanent teeth and other complications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013903107	GS1

Premarket Submissions

Submission Number	Supplement Number
K250343	000