EQUIA® 452011

GUDID 00386040010576

EQUIA® Forte Fil Single Shade Refill (48 capsules)- A2

Gc America Inc.

Glass ionomer dental cement

• Primary Device ID: 00386040010576
• NIH Device Record Key: adfdce33-edae-418a-94b7-f92f6c890381
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EQUIA®
• Version Model Number: 452011
• Catalog Number: 452011
• 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: true
• 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	00386040010576 [Unit of Use]
GS1	10386040010573 [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: 2022-07-21
• Device Publish Date: 2022-07-13

On-Brand Devices [EQUIA®]

• 00386040013874: EQUIA® Forte Intro Kit (48 Capsules of A3, EQUIA Forte Coat, Cavity Conditioner, & accessories
• 10386040010849: EQUIA Forte HT Refill (48) Pac
• 00386040010835: EQUIA Forte HT Refill (48) Pac
• 00386040010828: EQUIA Forte HT Refill (48) Pac
• 00386040010811: EQUIA Forte HT Refill (48) Pac
• 00386040010804: EQUIA Forte HT Refill (48) Pac
• 00386040010798: EQUIA Forte HT Refill (48) Pac
• 00386040010781: EQUIA Forte HT Refill (48) Pac
• 00386040010774: EQUIA Forte HT Refill (48) Pac
• 00386040010767: EQUIA Forte HT Assorted Refill
• 00386040010743: EQUIA® Forte Coat (50 unit dose & accessories)
• 10386040010733: Equia® Forte Coat (4mL bottle & accessories)
• 00386040010637: EQUIA® Forte Fil Single Shade Refill (48 capsules)- C4
• 00386040010620: EQUIA® Forte Fil Single Shade Refill (48 capsules)- B3
• 00386040010613: EQUIA® Forte Fil Single Shade Refill (48 capsules)- B2
• 00386040010606: EQUIA® Forte Fil Single Shade Refill (48 capsules)- B1
• 00386040010590: EQUIA® Forte Fil Single Shade Refill (48 capsules)- A3.5
• 00386040010583: EQUIA® Forte Fil Single Shade Refill (48 capsules)- A3
• 00386040010576: EQUIA® Forte Fil Single Shade Refill (48 capsules)- A2
• 00386040010569: EQUIA® Forte Fil Single Shade Refill (48 capsules) - A1
• 00386040010552: EQUIA® Forte Intro Kit (48 Capsules of C4, EQUIA Forte Coat, Cavity Conditioner, & accessories)
• 00386040010545: EQUIA® Forte Intro Kit (48 Capsules of B3, EQUIA Forte Coat, Cavity Conditioner, & accessories)
• 00386040010538: EQUIA® Forte Intro Kit (48 Capsules of B2, EQUIA Forte Coat, Cavity Conditioner, & accessories)
• 00386040010521: EQUIA® Forte Intro Kit (48 Capsules of B1, EQUIA Forte Coat, Cavity Conditioner, & accessories)
• 00386040010514: EQUIA® Forte Intro Kit Assorted (48 Capsules) (10 each of A2, A3, A3.5, 9 each of B1 & B3, EQUI
• 00386040010507: EQUIA® Forte Intro Kit (48 Capsules of A3.5, EQUIA Forte Coat, Cavity Conditioner, & accessorie
• 00386040010491: EQUIA® Forte Intro Kit (48 Capsules of A2, EQUIA Forte Coat, Cavity Conditioner, & accessories)
• 00386040010484: EQUIA® Forte Intro Kit (48 Capsules of A1, EQUIA Forte Coat, Cavity Conditioner, & accessories
• 00386040010477: EQUIA Forte Fil® Capsule Assorted (48 Capsules) (10 each of A2, A3, A3.5, 9 each of B1 & B3)
• 00386040012648: EQUIA Forte HT Intro (48) A2 - US
• 00386040012631: EQUIA Forte HT Intro (48) C4