ALPHA-DENT® Self Cure Bracket Bonding Resin 210.0101.001

GUDID D73521001010010

ALPHA-DENT® Self Cure Bracket Bonding Resin is a self cure two paste system formulated to bond to metal, ceramic and plastic brackets. The unique filler combination used in the pastes produces a superior bond when used with Self Cure Bracket Bonding Resin and minimized bond failures. Kit Contains: 1 x 7ml Bracket Bonding Base

DENTAL TECHNOLOGIES, INC.

Dentine bonding agent/set

• Primary Device ID: D73521001010010
• NIH Device Record Key: 63ee69cd-f3d8-4853-b75c-58143df6d7f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALPHA-DENT® Self Cure Bracket Bonding Resin
• Version Model Number: 210.0101.001
• Catalog Number: 210.0101.001
• Company DUNS: 148312838
• Company Name: DENTAL TECHNOLOGIES, 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: 847-677-5500
• Email: info@dentaltech.com
• Phone: 847-677-5500
• Email: info@dentaltech.com
• Phone: 847-677-5500
• Email: info@dentaltech.com
• Phone: 847-677-5500
• Email: info@dentaltech.com
• Phone: 847-677-5500
• Email: info@dentaltech.com
• Phone: 847-677-5500
• Email: info@dentaltech.com
• Phone: 847-677-5500
• Email: info@dentaltech.com
• Phone: 847-677-5500
• Email: info@dentaltech.com
• Phone: 847-677-5500
• Email: info@dentaltech.com
• Phone: 847-677-5500
• Email: info@dentaltech.com
• Phone: 847-677-5500
• Email: info@dentaltech.com
• Phone: 847-677-5500
• Email: info@dentaltech.com
• Phone: 847-677-5500
• Email: info@dentaltech.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D73521001010010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930614

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: 4
• Public Version Date: 2024-02-16
• Device Publish Date: 2016-09-23

On-Brand Devices [ALPHA-DENT® Self Cure Bracket Bonding Resin]

• D73521001020010: ALPHA-DENT® Self Cure Bracket Bonding Resin is a self cure two paste system formulated to bond
• D73521001010010: ALPHA-DENT® Self Cure Bracket Bonding Resin is a self cure two paste system formulated to bond