LUXEN Zr

GUDID 08800046907033

DENTALMAX CO.,LTD

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800046907033
• NIH Device Record Key: 953d6c39-1052-453c-9e29-bd2ea32b7138
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUXEN Zr
• Version Model Number: LUXEN 1100-12T-D95-MD2
• 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	08800046907033 [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 Zr]

• 08800046907231: LUXEN 1100-30T-D95-MD4
• 08800046907224: LUXEN 1100-25T-D95-MD4
• 08800046907217: LUXEN 1100-22T-D95-MD4
• 08800046907200: LUXEN 1100-18T-D95-MD4
• 08800046907194: LUXEN 1100-16T-D95-MD4
• 08800046907187: LUXEN 1100-14T-D95-MD4
• 08800046907170: LUXEN 1100-12T-D95-MD4
• 08800046907163: LUXEN 1100-30T-D95-MD3
• 08800046907156: LUXEN 1100-25T-D95-MD3
• 08800046907149: LUXEN 1100-22T-D95-MD3
• 08800046907132: LUXEN 1100-18T-D95-MD3
• 08800046907125: LUXEN 1100-16T-D95-MD3
• 08800046907118: LUXEN 1100-14T-D95-MD3
• 08800046907101: LUXEN 1100-12T-D95-MD3
• 08800046907095: LUXEN 1100-30T-D95-MD2
• 08800046907088: LUXEN 1100-25T-D95-MD2
• 08800046907071: LUXEN 1100-22T-D95-MD2
• 08800046907064: LUXEN 1100-18T-D95-MD2
• 08800046907057: LUXEN 1100-16T-D95-MD2
• 08800046907040: LUXEN 1100-14T-D95-MD2
• 08800046907033: LUXEN 1100-12T-D95-MD2
• 08800046907026: LUXEN 1100-30T-D95-MC4
• 08800046907019: LUXEN 1100-25T-D95-MC4
• 08800046907002: LUXEN 1100-22T-D95-MC4
• 08800046906999: LUXEN 1100-18T-D95-MC4
• 08800046906982: LUXEN 1100-16T-D95-MC4
• 08800046906975: LUXEN 1100-14T-D95-MC4
• 08800046906968: LUXEN 1100-12T-D95-MC4
• 08800046906951: LUXEN 1100-25T-D95-MC3
• 08800046906944: LUXEN 1100-25T-D95-MC3
• 08800046906937: LUXEN 1100-22T-D95-MC3
• 08800046906920: LUXEN 1100-18T-D95-MC3
• 08800046906913: LUXEN 1100-16T-D95-MC3
• 08800046906906: LUXEN 1100-14T-D95-MC3
• 08800046906890: LUXEN 1100-12T-D95-MC3
• 08800046906883: LUXEN 1100-30T-D95-MC2
• 08800046906876: LUXEN 1100-25T-D95-MC2
• 08800046906869: LUXEN 1100-22T-D95-MC2
• 08800046906852: LUXEN 1100-18T-D95-MC2
• 08800046906845: LUXEN 1100-16T-D95-MC2
• 08800046906838: LUXEN 1100-14T-D95-MC2
• 08800046906821: LUXEN 1100-12T-D95-MC2
• 08800046906814: LUXEN 1100-30T-D95-MC1
• 08800046906807: LUXEN 1100-25T-D95-MC1
• 08800046906791: LUXEN 1100-22T-D95-MC1
• 08800046906784: LUXEN 1100-18T-D95-MC1
• 08800046906777: LUXEN 1100-16T-D95-MC1
• 08800046906760: LUXEN 1100-14T-D95-MC1
• 08800046906753: LUXEN 1100-12T-D95-MC1
• 08800046906746: LUXEN 1100-30T-D95-MB4