LUXEN Smile

Basic Information

• Brand Name: LUXEN Smile
• Primary DI: 08800046913508
• Version / Model: Luxen Smile SE-22T-D98-A1
• Company Name: DENTALMAX CO.,LTD
• Labeler DUNS: 688528450
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-04
• Public Version: 1
• Public Version Date: 2022-02-14
• Public Version Status: New
• Public Device Record Key: 4e7216cb-d503-4699-99b6-2615d05bfecb

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIH	Powder, Porcelain	Dental	872.6660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16187	Dental appliance fabrication material, ceramic	A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800046913508	GS1

Premarket Submissions

Submission Number	Supplement Number
K171585	000