Alpha-Crown® 113.0008.002

GUDID D73511300080020

Alpha-Crown® crown & bridge material is specifically designed for fabricating temporary crowns and bridges with ease and convenience. The static mixing tip provides automatic mixing from the dual chambered cartridge to greatly reduce in-office procedure time. The Bix-acryl material is very durable, color stable, and water resistant. The greater flexibility facilitates deformation free removal of the material from the patient's mouth. Alpha-Crown® contains fluorescence to provide a duplication of the natural tooth surface. Kit Contains: 74g Cartridge (Shade A3.5), 10 Automix Tips

DENTAL TECHNOLOGIES, INC.

Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin

• Primary Device ID: D73511300080020
• NIH Device Record Key: 63038da8-329c-4093-920b-ac1f6c2ed959
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alpha-Crown®
• Version Model Number: 113.0008.002
• Catalog Number: 113.0008.002
• 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

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
• 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	D73511300080020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960122

FDA Product Code

• EBG: Crown And Bridge, Temporary, 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: 2021-10-29
• Device Publish Date: 2016-09-23

On-Brand Devices [Alpha-Crown®]

• D73511300090020: Alpha-Crown® crown & bridge material is specifically designed for fabricating temporary crowns
• D73511300080020: Alpha-Crown® crown & bridge material is specifically designed for fabricating temporary crowns
• D73511300070020: Alpha-Crown® crown & bridge material is specifically designed for fabricating temporary crowns
• D73511300060020: Alpha-Crown® crown & bridge material is specifically designed for fabricating temporary crowns
• D73511300050020: Alpha-Crown® crown & bridge material is specifically designed for fabricating temporary crowns