FIT CHECKER™ BLUE 004905

GUDID 14548161297264

FIT CHECKER™Advanced BLUE Cartridge Package (2 x 48 mL cartridges, 6 x mixing tips)

Gc America Inc.

Silicone dental impression material

• Primary Device ID: 14548161297264
• NIH Device Record Key: 791296fe-6c67-4601-bb2e-fa047f934dd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIT CHECKER™ BLUE
• Version Model Number: 004905
• Catalog Number: 004905
• 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

Device Dimensions

• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter
• Total Volume: 48 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 0
• Storage Environment Temperature: Between 23 Degrees Celsius and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	14548161297264 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120521

FDA Product Code

• ELW: MATERIAL, IMPRESSION

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: 2022-08-15
• Device Publish Date: 2022-08-05

Devices Manufactured by Gc America Inc.

• D0470095414 - G-CEM LinkForce™: 2025-03-17 G-CEM LinkForce™ System Kit 3 LinkForce syringes (8.7g) one each of A2, Translucent Opaque, 45 regular mixing tips, 5 endo mix
• D0470095534 - G-Multi PRIMER: 2025-03-17 G-Multi PRIMER 5mL, 1 btl. 5mL
• D0470101184 - G-CEM LinkForce™: 2025-03-17 G-CEM LinkForce™ Starter Kit A2, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5mL, 1 bottle G-Multi Primer 5mL, 20 regul
• D0470101194 - G-CEM LinkForce™: 2025-03-17 G-CEM LinkForce™ Starter Kit Translucent, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5mL, 1 bottle G-Multi Primer 5mL,
• D0470101204 - G-CEM LinkForce™: 2025-03-17 G-CEM LinkForce™ Cement Refill A2, 1 syringe (8.7g/5mL), 20 regular mixing tips
• D0470101214 - G-CEM LinkForce™: 2025-03-17 G-CEM LinkForce™ Cement Refill Translucent, 1 syringe (8.7g/5mL), 20 regular mixing tips
• D0470101224 - G-CEM LinkForce™: 2025-03-17 G-CEM LinkForce™ Cement Refill Opaque, 1 syringe (8.7g/5mL), 20 regular mixing tips
• D0470101234 - G-CEM LinkForce™: 2025-03-17 G-CEM LinkForce™ Cement Refill Bleach, 1 syringe (8.7g/5mL) 20 regular mixing tips