LUXEN Smile, LUXEN Zr

GUDID 08800046945530

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

• Primary Device ID: 08800046945530
• NIH Device Record Key: 629f0d2a-b5f1-4ce4-ba1a-ac1c3dda6088
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUXEN Smile, LUXEN Zr
• Version Model Number: ML 1200 600 Multi P D95 B4 22T
• 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	08800046945530 [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: 2022-02-14
• Device Publish Date: 2022-02-06

On-Brand Devices [LUXEN Smile, LUXEN Zr]

• 08800046977241: Zr-10T-D98-HT
• 08800119910779: ML 1200 600 Multi P D95 MHT Dark 12T
• 08800119910762: ML 1200 600 Multi P D95 MHT Dark 14T
• 08800119910755: ML 1200 600 Multi P D95 MHT Dark 16T
• 08800119910748: ML 1200 600 Multi P D95 MHT Dark 18T
• 08800119910731: ML 1200 600 Multi P D95 MHT Dark 20T
• 08800119910724: ML 1200 600 Multi P D95 MHT Dark 22T
• 08800119910717: ML 1200 600 Multi P D95 MHT Dark 25T
• 08800119910700: ML 1200 600 Multi P D95 MHT Dark 28T
• 08800119910694: ML 1200 600 Multi P D95 MHT Dark 30T
• 08800119910687: ML 1200 600 Multi P D95 MHT Light 12T
• 08800119910670: ML 1200 600 Multi P D95 MHT Light 14T
• 08800119910663: ML 1200 600 Multi P D95 MHT Light 16T
• 08800119910656: ML 1200 600 Multi P D95 MHT Light 18T
• 08800119910649: ML 1200 600 Multi P D95 MHT Light 20T
• 08800119910632: ML 1200 600 Multi P D95 MHT Light 22T
• 08800119910625: ML 1200 600 Multi P D95 MHT Light 25T
• 08800119910618: ML 1200 600 Multi P D95 MHT Light 28T
• 08800119910601: ML 1200 600 Multi P D95 MHT Light 30T
• 08800119910595: ML 1200 600 Multi P D95 MHT Medium 12T
• 08800119910588: ML 1200 600 Multi P D95 MHT Medium 14T
• 08800119910571: ML 1200 600 Multi P D95 MHT Medium 16T
• 08800119910564: ML 1200 600 Multi P D95 MHT Medium 18T
• 08800119910557: ML 1200 600 Multi P D95 MHT Medium 20T
• 08800119910540: ML 1200 600 Multi P D95 MHT Medium 22T
• 08800119910533: ML 1200 600 Multi P D95 MHT Medium 25T
• 08800119910526: ML 1200 600 Multi P D95 MHT Medium 28T
• 08800119910519: ML 1200 600 Multi P D95 MHT Medium 30T
• 08800119910502: ML 1200 600 Multi P D98 MHT Dark 12T
• 08800119910496: ML 1200 600 Multi P D98 MHT Dark 14T
• 08800119910489: ML 1200 600 Multi P D98 MHT Dark 16T
• 08800119910472: ML 1200 600 Multi P D98 MHT Dark 18T
• 08800119910465: ML 1200 600 Multi P D98 MHT Dark 20T
• 08800119910458: ML 1200 600 Multi P D98 MHT Dark 22T
• 08800119910441: ML 1200 600 Multi P D98 MHT Dark 25T
• 08800119910434: ML 1200 600 Multi P D98 MHT Dark 28T
• 08800119910427: ML 1200 600 Multi P D98 MHT Dark 30T
• 08800119910410: ML 1200 600 Multi P D98 MHT Light 12T
• 08800119910403: ML 1200 600 Multi P D98 MHT Light 14T
• 08800119910397: ML 1200 600 Multi P D98 MHT Light 16T
• 08800119910380: ML 1200 600 Multi P D98 MHT Light 18T
• 08800119910373: ML 1200 600 Multi P D98 MHT Light 20T
• 08800119910366: ML 1200 600 Multi P D98 MHT Light 22T
• 08800119910359: ML 1200 600 Multi P D98 MHT Light 25T
• 08800119910342: ML 1200 600 Multi P D98 MHT Light 28T
• 08800119910335: ML 1200 600 Multi P D98 MHT Light 30T
• 08800119910328: ML 1200 600 Multi P D98 MHT Medium 12T
• 08800119910311: ML 1200 600 Multi P D98 MHT Medium 14T
• 08800119910304: ML 1200 600 Multi P D98 MHT Medium 16T
• 08800119910298: ML 1200 600 Multi P D98 MHT Medium 18T