EQUIA 453005

GUDID 00386040012624

EQUIA Forte HT Intro Assorted (48)

Gc America Inc.

Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement

• Primary Device ID: 00386040012624
• NIH Device Record Key: b039f1e4-7379-4201-9a9a-d6838e3d706a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EQUIA
• Version Model Number: 453005
• Catalog Number: 453005
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 48
• 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 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386040012624 [Unit of Use]
GS1	10386040012621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091106

FDA Product Code

• EMA: CEMENT, DENTAL

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: 2022-08-01
• Device Publish Date: 2022-07-22

On-Brand Devices [EQUIA]

• 00386040012624: EQUIA Forte HT Intro Assorted (48)
• 00386040012617: EQUIA Forte HT Intro (48) A3.5
• 00386040012600: EQUIA Forte HT Intro (48) A3
• 00386040012594: EQUIA Forte HT Intro (48) A1