Ultra Band-Lok

GUDID 00817573023653

ULTRA BAND-LOK BLUE SYRINGE KIT (5g)

LANCER ORTHODONTICS, INC.

Fatty acid dental cement

• Primary Device ID: 00817573023653
• NIH Device Record Key: 7e64c34a-262e-45fd-85df-ba5883ee8baf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra Band-Lok
• Version Model Number: 811-403
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817573023653 [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: 2017-01-14

On-Brand Devices [Ultra Band-Lok]

• 00817573023660: ULTRA BAND-LOK NATURAL SYRINGE KIT (5g)
• 00817573023653: ULTRA BAND-LOK BLUE SYRINGE KIT (5g)