ALIKE™ 340501

GUDID 10386040006705

ALIKE™ Professional Package (1 x A1 45g powder, 1 x A2 45g powder, 1 x A3 45g powder, 1 x A3.5 45g powder 1 x B1 45g powder, 1 x B2 45g powder, 1 x B3 45g powder)

Gc America Inc.

Temporary dental crown/bridge

• Primary Device ID: 10386040006705
• NIH Device Record Key: 4a37b825-5848-4980-8aad-aee54c7931d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALIKE™
• Version Model Number: 340501
• Catalog Number: 340501
• Company DUNS: 005473608
• Company Name: Gc America 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: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 21 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386040006705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833261

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-15
• Device Publish Date: 2022-07-07

On-Brand Devices [ALIKE™]

• D6583405911: ALIKE™ 4oz liquid
• D6583405261: ALIKE™ A3.5, 170g powder
• D6583405251: ALIKE™ B3, 170g powder
• D6583405241: ALIKE™ A3, 170g powder
• D6583405231: ALIKE™ A2, 170g powder
• D6583405221: ALIKE™ A1, 170g powder
• D6583405211: ALIKE™ B1, 170g powder
• D6583405161: ALIKE™ A3.5, 45g powder
• D6583405151: ALIKE™ B3, 45g powder
• D6583405141: ALIKE™ A3, 45g powder
• D6583405131: ALIKE™ A2, 45g powder
• D6583405121: ALIKE™ A1, 45g powder
• D6583405111: ALIKE™ B1, 45g powder
• D6583405011: ALIKE™ Professional Package (1 x A1 45g powder, 1 x A2 45g powder, 1 x A3 45g powder, 1 x A3.5
• 10386040006842: ALIKE™ 4oz liquid
• 10386040006828: ALIKE™ A3.5, 170g powder
• 10386040006811: ALIKE™ B3, 170g powder
• 10386040006804: ALIKE™ A3, 170g powder
• 10386040006798: ALIKE™ A2, 170g powder
• 10386040006781: ALIKE™ A1, 170g powder
• 10386040006774: ALIKE™ B1, 170g powder
• 10386040006767: ALIKE™ A3.5, 45g powder
• 10386040006750: ALIKE™ B3, 45g powder
• 10386040006743: ALIKE™ A3, 45g powder
• 10386040006736: ALIKE™ A2, 45g powder
• 10386040006729: ALIKE™ A1, 45g powder
• 10386040006712: ALIKE™ B1, 45g powder
• 10386040006705: ALIKE™ Professional Package (1 x A1 45g powder, 1 x A2 45g powder, 1 x A3 45g powder, 1 x A3.5