COE® ORTHO ALGINATE 121630

GUDID D6581216301

COE® ORTHO ALGINATE Mint 1 lb. pouch

Gc America Inc.

Silicone dental impression material

• Primary Device ID: D6581216301
• NIH Device Record Key: 883a4251-7685-4edd-8025-a9a45577bcb1
• Commercial Distribution Discontinuation: 2020-07-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: COE® ORTHO ALGINATE
• Version Model Number: 121630
• Catalog Number: 121630
• 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
• 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
• 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
HIBCC	D6581216301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894282

FDA Product Code

• ELW: MATERIAL, IMPRESSION

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: 2020-07-29
• Device Publish Date: 2017-05-01

Devices Manufactured by Gc America Inc.

• D0470001812 - GC Fuji II LC®: 2025-02-03 GC Fuji II LC® Core 1-2 Package (1 x 35 g powder, 2 x 5 mL liquid, 1 x scoop, 1 x mixing pad)
• D0470001822 - GC Fuji II LC®: 2025-02-03 GC Fuji II LC® Core 35 g powder btl.
• D0470001832 - GC Fuji II LC®: 2025-02-03 GC Fuji II LC® Core (5.1mL) liquid btl
• D0470001842 - GC Fuji II LC®: 2025-02-03 GC Fuji II LC® A1, 1-1 Pack (1 x 15 g powder, 1 x 6.8 mL liquid & accessories)
• D0470001852 - GC Fuji II LC®: 2025-02-03 GC Fuji II LC® A2, 1-1 Pack (1 x 15 g powder, 1 x 6.8mL liquid & accessories)
• D0470001862 - GC Fuji II LC®: 2025-02-03 GC Fuji II LC® A3, 1-1 Pack (1 x 15 g powder, 1 x 6.8 mL liquid & accessories)
• D0470001871 - GC Fuji II LC®: 2025-02-03 GC Fuji II LC® A3.5, 1-1 Pack (1 x 15 g powder, 1 x 6.8mL liquid & accessories)
• D0470001881 - GC Fuji II LC®: 2025-02-03 GC Fuji II LC® A4, 1-1 Pack (1 x 15 g powder, 1 x 6.8 mL liquid & accessories)