Assure APP

GUDID D798APP0

Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention.

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive

• Primary Device ID: D798APP0
• NIH Device Record Key: ad7c26b4-1cf2-4435-ad25-b3a900aa9a24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure
• Version Model Number: APP
• Catalog Number: APP
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store Refrigerated (2-8 C). Protect from heat and light.
• Special Storage Condition, Specify: Between 0 and 0 *Store Refrigerated (2-8 C). Protect from heat and light.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798APP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895522

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: 2016-07-25

On-Brand Devices [Assure ]

• D798AS0: Assure® Universal Bonding Resin is intended to increase adhesion to wet or dry, norm
• D798APP0: Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can b