LUXEN CL

GUDID 08800046999878

DENTALMAX CO.,LTD

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800046999878
• NIH Device Record Key: 9f84418e-f478-4a31-a71e-24a3805f2bf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUXEN CL
• Version Model Number: Luxen CL-Deep Amber 50ml
• 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	08800046999878 [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: 2023-12-29
• Device Publish Date: 2023-12-21

On-Brand Devices [LUXEN CL ]

• 08800046980722: Luxen CL-A1D 100ml
• 08800046980708: Luxen CL-A1D 30ml
• 08800046982238: Luxen CL-Cervical D 50ml
• 08800046982221: Luxen CL-Cervical D 30ml
• 08800046982214: Luxen CL-Cervical D 10ml
• 08800046982207: Luxen CL-Cervical C 100ml
• 08800046982191: Luxen CL-Cervical C 50ml
• 08800046982184: Luxen CL-Cervical C 30ml
• 08800046982177: Luxen CL-Cervical C 10ml
• 08800046982160: Luxen CL-Cervical B 100ml
• 08800046982153: Luxen CL-Cervical B 50ml
• 08800046982146: Luxen CL-Cervical B 30ml
• 08800046982139: Luxen CL-Cervical B 10ml
• 08800046982122: Luxen CL-Cervical A 100ml
• 08800046982115: Luxen CL-Cervical A 50ml
• 08800046982108: Luxen CL-Cervical A 30ml
• 08800046982092: Luxen CL-Cervical A 10ml
• 08800046982085: Luxen CL-White Enamel 100ml
• 08800046982078: Luxen CL-White Enamel 50ml
• 08800046982061: Luxen CL-White Enamel 30ml
• 08800046982054: Luxen CL-White Enamel 10ml
• 08800046982047: Luxen CL-White 100ml
• 08800046982030: Luxen CL-White 50ml
• 08800046982023: Luxen CL-White 30ml
• 08800046982016: Luxen CL-White 10ml
• 08800046982009: Luxen CL-Creamy White 100ml
• 08800046981996: Luxen CL-Creamy White 50ml
• 08800046981989: Luxen CL-Creamy White 30ml
• 08800046981972: Luxen CL-Creamy White 10ml
• 08800046981965: Luxen CL-White Opaque 100ml
• 08800046981958: Luxen CL-White Opaque 50ml
• 08800046981941: Luxen CL-White Opaque 30ml
• 08800046981934: Luxen CL-White Opaque 10ml
• 08800046981927: Luxen CL-Brown 100ml
• 08800046981910: Luxen CL-Brown 50ml
• 08800046981903: Luxen CL-Brown 30ml
• 08800046981897: Luxen CL-Brown 10ml
• 08800046981880: Luxen CL-Amber 100ml
• 08800046981873: Luxen CL-Amber 50ml
• 08800046981866: Luxen CL-Amber 30ml
• 08800046981859: Luxen CL-Amber 10ml
• 08800046981842: Luxen CL-Yellow 100ml
• 08800046981835: Luxen CL-Yellow 50ml
• 08800046981828: Luxen CL-Yellow 30ml
• 08800046981811: Luxen CL-Yellow 10ml
• 08800046981804: Luxen CL-Natural Gray 2 100ml
• 08800046981798: Luxen CL-Natural Gray 2 50ml
• 08800046981781: Luxen CL-Natural Gray 2 30ml
• 08800046981774: Luxen CL-Natural Gray 2 10ml
• 08800046981767: Luxen CL-Natural Gray 1 100ml