LUXEN Smile

GUDID 08800046903868

DENTALMAX CO.,LTD

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800046903868
• NIH Device Record Key: dc3ff155-cdcd-4b49-b2b7-a2fbe91fc4fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUXEN Smile
• Version Model Number: LUXEN Smile-25T-D98-MB4
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800046903868 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171585

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: 2019-05-16
• Device Publish Date: 2019-05-08

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