GUDID 00817573023288

REL-ADHESIVE PRIMER

LANCER ORTHODONTICS, INC.

Fatty acid dental cement

• Primary Device ID: 00817573023288
• NIH Device Record Key: d21d74bd-2c1b-4f49-8873-99b675f2494e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 811-012RM
• 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	00817573023288 [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: 2017-01-12

Devices Manufactured by LANCER ORTHODONTICS, INC.

• 00817573020003 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH CEN +12T +5A 018 UL
• 00817573020010 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH LAT +8T +9A 018 UR
• 00817573020027 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH LAT +8T +9A 018 UL
• 00817573020034 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH CUS HK 0T +11A 018 UR
• 00817573020041 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH CUS HK 0T +11A 018 UL
• 00817573020058 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH CUS0T +11A 018 UR
• 00817573020065 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH CUS0T +11A 018 UL
• 00817573020072 - Intrigue: 2018-07-06 INTRG WHISP-Z ROTH BIC HK -7T 0A 018 UR