ASSURE UNIVERSAL BONDING RESIN

GUDID 00840479200897

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive

• Primary Device ID: 00840479200897
• NIH Device Record Key: ddcf04db-ad56-400a-8c7a-22afff3958e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSURE UNIVERSAL BONDING RESIN
• Version Model Number: BI4MLAS
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840479200897 [Primary]
HIBCC	D798BI4MLAS0 [Previous]

FDA Product Code

• KLE: Agent, Tooth Bonding, 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: 2026-03-03
• Device Publish Date: 2026-02-23

On-Brand Devices [ASSURE UNIVERSAL BONDING RESIN]

• D798BI4MLAS0: Assure® Universal Bonding Resin is hydrophilic so the etched enamel can be dry or slightly cont
• D798AS2ML0: Assure® Universal Bonding Resin is hydrophilic so the etched enamel can be dry or slightly cont
• 00840479200897: BI4MLAS
• 00840479200767: AS