Bond Aligner 1 BA

GUDID D7981BA0

Bond Aligner® is intended for use as an orthodontic bonding adhesive for brackets and appliances to thermoplastic aligner surfaces. Can also be used for forming button attachments. Bond Aligner is formulated to work with clear, thermoforming aligner plastics. It is not recommended for use with cloudy (Class C) thermoforming materials. Bond Aligner is a clear, light cure adhesive to adhere metal, ceramic or plastic attachments to a thermoplastic aligner.

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive

• Primary Device ID: D7981BA0
• NIH Device Record Key: fba33195-9a22-49b2-ae81-496dc4859ef0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bond Aligner
• Version Model Number: 1BA
• Catalog Number: 1 BA
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS 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

Customer Support Contacts

• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15 - 30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15 - 30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15 - 30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15 - 30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15 - 30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15 - 30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15 - 30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15 - 30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15 - 30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15 - 30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15 - 30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15 - 30 Degrees C)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15 - 30 Degrees C)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7981BA0 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-27
• Device Publish Date: 2020-07-17

On-Brand Devices [Bond Aligner ]

• D798BA0: Bond Aligner® is intended for use as an orthodontic bonding adhesive for brackets and appliance
• D7981BA0: Bond Aligner® is intended for use as an orthodontic bonding adhesive for brackets and appliance