LUXEN 5G

GUDID 08809900579591

DENTALMAX CO.,LTD

Dental appliance fabrication material, ceramic

• Primary Device ID: 08809900579591
• NIH Device Record Key: d6562422-8103-43de-bcc2-9eb0cf172198
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUXEN 5G
• Version Model Number: Luxen Zr 4019 S1
• Company DUNS: 688528450
• Company Name: DENTALMAX CO.,LTD
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809900540003 [Primary]
GS1	08809900579591 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241151

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-17
• Device Publish Date: 2025-02-07

On-Brand Devices [LUXEN 5G]

• 08809900572943: Luxen Smile GL D98 D3 12T
• 08809900572936: Luxen Smile GL D98 D3 10T
• 08809900572929: Luxen Smile GL D98 D2 30T
• 08809900572912: Luxen Smile GL D98 D2 28T
• 08809900572905: Luxen Smile GL D98 D2 25T
• 08809900572899: Luxen Smile GL D98 D2 22T
• 08809900572882: Luxen Smile GL D98 D2 20T
• 08809900572875: Luxen Smile GL D98 D2 18T
• 08809900572868: Luxen Smile GL D98 D2 16T
• 08809900572851: Luxen Smile GL D98 D2 14T
• 08809900572844: Luxen Smile GL D98 D2 12T
• 08809900572837: Luxen Smile GL D98 D2 10T
• 08809900572820: Luxen Smile GL D98 C4 30T
• 08809900572813: Luxen Smile GL D98 C4 28T
• 08809900572806: Luxen Smile GL D98 C4 25T
• 08809900572790: Luxen Smile GL D98 C4 22T
• 08809900572783: Luxen Smile GL D98 C4 20T
• 08809900572776: Luxen Smile GL D98 C4 18T
• 08809900572769: Luxen Smile GL D98 C4 16T
• 08809900572752: Luxen Smile GL D98 C4 14T
• 08809900572745: Luxen Smile GL D98 C4 12T
• 08809900572738: Luxen Smile GL D98 C4 10T
• 08809900572721: Luxen Smile GL D98 C3 30T
• 08809900572714: Luxen Smile GL D98 C3 28T
• 08809900572707: Luxen Smile GL D98 C3 25T
• 08809900572691: Luxen Smile GL D98 C3 22T
• 08809900572684: Luxen Smile GL D98 C3 20T
• 08809900572677: Luxen Smile GL D98 C3 18T
• 08809900572660: Luxen Smile GL D98 C3 16T
• 08809900572653: Luxen Smile GL D98 C3 14T
• 08809900572646: Luxen Smile GL D98 C3 12T
• 08809900572639: Luxen Smile GL D98 C3 10T
• 08809900572622: Luxen Smile GL D98 C2 30T
• 08809900572615: Luxen Smile GL D98 C2 28T
• 08809900572608: Luxen Smile GL D98 C2 25T
• 08809900572592: Luxen Smile GL D98 C2 22T
• 08809900572585: Luxen Smile GL D98 C2 20T
• 08809900572578: Luxen Smile GL D98 C2 18T
• 08809900572561: Luxen Smile GL D98 C2 16T
• 08809900572554: Luxen Smile GL D98 C2 14T
• 08809900572547: Luxen Smile GL D98 C2 12T
• 08809900572530: Luxen Smile GL D98 C2 10T
• 08809900572523: Luxen Smile GL D98 C1 30T
• 08809900572516: Luxen Smile GL D98 C1 28T
• 08809900572509: Luxen Smile GL D98 C1 25T
• 08809900572493: Luxen Smile GL D98 C1 22T
• 08809900572486: Luxen Smile GL D98 C1 20T
• 08809900572479: Luxen Smile GL D98 C1 18T
• 08809900572462: Luxen Smile GL D98 C1 16T
• 08809900572455: Luxen Smile GL D98 C1 14T