Fuji

GUDID 00817573024483

FUJI ORTHO-SELF CURE CEMENT STANDARD

LANCER ORTHODONTICS, INC.

Fatty acid dental cement

• Primary Device ID: 00817573024483
• NIH Device Record Key: bff6f177-9b50-4b10-a35c-9749db8467e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fuji
• Version Model Number: D11-4357
• Company DUNS: 045545589
• Company Name: LANCER ORTHODONTICS, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit
• Handling Environment Temperature: Between 37 Degrees Fahrenheit and 50 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817573024483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904090

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-15

On-Brand Devices [Fuji]

• 00817573024544: FUJI ORTHO PWD ONLY 40 6M
• 00817573024537: FUJI ORTHO CONDITIONER ONLY 25GM
• 00817573024520: FUJI ORTHO LIQ ONLY 8 6M
• 00817573024513: FUJI ORTHO-LC GLASS CEMENT STANDARD
• 00817573024506: FUJI ORTHO-LITE CURE INTRO
• 00817573024483: FUJI ORTHO-SELF CURE CEMENT STANDARD
• 00817573024469: GC FUJI ORTHO BAND PASTE REFILL
• 00817573024452: GC FUJI ORTHO BAND PASTE
• 00817573024445: FUJI ORTHO-SELF CURE CEMENT STARTER
• 00817573024438: GC FUJI CAPSULE APPLIER II
• 00817573024421: GC FUJI LC CAPSULES REFILL PACKAGE
• 00817573024414: GC FUJI LC CAPSULES STARTER KIT