Advantage

GUDID 00190707000714

ADVANTAGE PORCELAIN CONDITIONER

ORTHO ORGANIZERS, INC.

Orthodontic bracket adhesive

• Primary Device ID: 00190707000714
• NIH Device Record Key: 3f815ad3-118a-4276-9157-4ccdd49ed507
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advantage
• Version Model Number: 480-013
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: true
• 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 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190707000714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921044

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: 2016-09-24

Devices Manufactured by ORTHO ORGANIZERS, INC.

• 00190707128975 - Band Assemblies: 2025-07-15 .022 Elite LR6 Conv DBT -25T/0A/+4Off Tempra - Cleat 44
• 00190707128982 - Band Assemblies: 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 33
• 00190707128999 - Band Assemblies: 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 33.5
• 00190707129002 - Band Assemblies: 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 34
• 00190707129019 - Band Assemblies: 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 34.5
• 00190707129026 - Band Assemblies: 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 35
• 00190707129033 - Band Assemblies: 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 35.5
• 00190707129040 - Band Assemblies: 2025-07-15 Elite.022/.045 UR6 Conv CBTBuccal Tube Tempra 36