Luxen Smile

GUDID 08809900538079

DENTALMAX CO.,LTD

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic

• Primary Device ID: 08809900538079
• NIH Device Record Key: 0a261e20-2039-4135-a291-e275707fa3e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luxen Smile
• Version Model Number: M35PD_9816_BLW
• Company DUNS: 688528450
• Company Name: DENTALMAX CO.,LTD
• Device Count: 1
• 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	08809900538079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212548

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: 2022-11-28
• Device Publish Date: 2022-11-18

On-Brand Devices [Luxen Smile]

• 08800046909976: Galaxy Clear 95 MD3-30T
• 08800046909969: Galaxy Clear 95 MD3-25T
• 08800046909952: Galaxy Clear 95 MD3-22T
• 08800046909945: Galaxy Clear 95 MD3-18T
• 08800046909938: Galaxy Clear 95 MD3-16T
• 08800046909921: Galaxy Clear 95 MD3-14T
• 08800046909914: Galaxy Clear 95 MD3-12T
• 08800046909907: Galaxy Clear 95 MD2-30T
• 08800046909891: Galaxy Clear 95 MD2-25T
• 08800046909884: Galaxy Clear 95 MD2-22T
• 08800046909877: Galaxy Clear 95 MD2-18T
• 08800046909860: Galaxy Clear 95 MD2-16T
• 08800046909853: Galaxy Clear 95 MD2-14T
• 08800046909846: Galaxy Clear 95 MD2-12T
• 08800046909839: Galaxy Clear 95 MC3-30T
• 08800046909822: Galaxy Clear 95 MC3-25T
• 08800046909815: Galaxy Clear 95 MC3-22T
• 08800046909808: Galaxy Clear 95 MC3-18T
• 08800046909792: Galaxy Clear 95 MC3-16T
• 08800046909785: Galaxy Clear 95 MC3-14T
• 08800046909778: Galaxy Clear 95 MC3-12T
• 08800046909761: Galaxy Clear 95 MC2-30T
• 08800046909754: Galaxy Clear 95 MC2-25T
• 08800046909747: Galaxy Clear 95 MC2-22T
• 08800046909730: Galaxy Clear 95 MC2-18T
• 08800046909723: Galaxy Clear 95 MC2-16T
• 08800046909716: Galaxy Clear 95 MC2-14T
• 08800046909709: Galaxy Clear 95 MC2-12T
• 08800046909693: Galaxy Clear 95 MC1-30T
• 08800046909686: Galaxy Clear 95 MC1-25T
• 08800046909679: Galaxy Clear 95 MC1-22T
• 08800046909662: Galaxy Clear 95 MC1-18T
• 08800046909655: Galaxy Clear 95 MC1-16T
• 08800046909648: Galaxy Clear 95 MC1-14T
• 08800046909631: Galaxy Clear 95 MC1-12T
• 08800046909624: LUXEN Smile-30T-D95-MB4
• 08800046909617: LUXEN Smile-25T-D95-MB4
• 08800046909600: LUXEN Smile-22T-D95-MB4
• 08800046909594: LUXEN Smile-18T-D95-MB4
• 08800046909587: LUXEN Smile-16T-D95-MB4
• 08800046909570: LUXEN Smile-14T-D95-MB4
• 08800046909563: LUXEN Smile-12T-D95-MB4
• 08800046909556: Galaxy Clear 95 MB3-30T
• 08800046909549: Galaxy Clear 95 MB3-25T
• 08800046909532: Galaxy Clear 95 MB3-22T
• 08800046909525: Galaxy Clear 95 MB3-18T
• 08800046909518: Galaxy Clear 95 MB3-16T
• 08800046909501: Galaxy Clear 95 MB3-14T
• 08800046909495: Galaxy Clear 95 MB3-12T
• 08800046909488: Galaxy Clear 95 MB2-30T