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 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