ALPHA-DENT® Self Cure Bonding Adhesive 200.0001.001

GUDID D73520000010010

ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal viscosity allows the material to penetrate into microtubules to enhance mechanical adhesion. Kit Contains: 3ml Base Adhesive, 3ml Catalyst Adhesive, 2 x 4g Etch Gel Syringes, Mixing Pad

DENTAL TECHNOLOGIES, INC.

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• Primary Device ID: D73520000010010
• NIH Device Record Key: e9348d49-fc9e-42fa-99fd-3b9776d42fe0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALPHA-DENT® Self Cure Bonding Adhesive
• Version Model Number: 200.0001.001
• Catalog Number: 200.0001.001
• 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: true
• 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	D73520000010010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984503

FDA Product Code

• KLE: Agent, Tooth Bonding, 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 Bonding Adhesive]

• D73520002020010: ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to den
• D73520001020010: ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to den
• D73520000010010: ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to den
• D73520000000010: ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to den