Assure Plus UAPSAM

GUDID D798UAPSAM1

Assure Plus resin is intended to increase adhesion to normal, atypical (wet or dry) enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel), porcelain, zirconia, composite restorations, acrylic temporary/pontic teeth. This is a Unidose dispensing system. Single unidose capsule

RELIANCE ORTHODONTIC PRODUCTS INC

Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set

• Primary Device ID: D798UAPSAM1
• NIH Device Record Key: 97edb3c4-3f8e-47ba-8288-c8e106b0245e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure Plus
• Version Model Number: UAPSAM
• Catalog Number: UAPSAM
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS 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: true
• 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: 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
• 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)
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature (15-30 Degrees C)

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798UAPSAM0 [Primary]
HIBCC	D798UAPSAM1 [Package]; Contains: D798UAPSAM0; Package: [50 Units]; In Commercial Distribution

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: 2020-05-27
• Device Publish Date: 2020-05-19

On-Brand Devices [Assure Plus ]

• D798UAP501: Assure Plus resin is intended to increase adhesion to normal, atypical (wet or dry) enamel surfa
• D798UAP1: Assure Plus resin is intended to increase adhesion to normal, atypical (wet or dry) enamel surfa
• D798UAPSAM1: Assure Plus resin is intended to increase adhesion to normal, atypical (wet or dry) enamel surfa