EQUIA® 452007
GUDID D6584520071
EQUIA® Forte Intro Kit (48 Capsules of B2, EQUIA Forte Coat, Cavity Conditioner, & accessories)
Gc America Inc.
Glass ionomer dental cement| Primary Device ID | D6584520071 |
| NIH Device Record Key | 6c9c6358-d3b3-4277-8129-ded3ba494711 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EQUIA® |
| Version Model Number | 452007 |
| Catalog Number | 452007 |
| 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 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| 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 |
| 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 |
|---|---|
| HIBCC | D6584520070 [Unit of Use] |
| HIBCC | D6584520071 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2026-01-21 |
| Device Publish Date | 2016-08-01 |
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 |
| D6584530170 | EQUIA Forte HT Refill (48) Pack - C4 |
| D6584530160 | EQUIA Forte HT Refill (48) Pack - B3 |
| D6584530150 | EQUIA Forte HT Refill (48) Pack - B2 |
| D6584530140 | EQUIA Forte HT Refill (48) Pack - B1 |
| D6584530130 | EQUIA Forte HT Refill (48) Pack - A3.5 |
| D6584530120 | EQUIA Forte HT Refill (48) Pack - A3 |
| D6584530110 | EQUIA Forte HT Refill (48) Pack - A2 |
| D6584530100 | EQUIA Forte HT Refill (48) Pack - A1 |
| D6584530090 | EQUIA Forte HT Intro (48) C4 |
| D6584530080 | EQUIA Forte HT Intro (48) B3 |
| D6584530070 | EQUIA Forte HT Intro (48) B2 |
| D6584530060 | EQUIA Forte HT Intro (48) B1 |
| D6584530050 | EQUIA Forte HT Intro Assorted (48) |
| D6584530040 | EQUIA Forte HT Intro (48) A3.5 |
| D6584530030 | EQUIA Forte HT Intro (48) A3 |
| D6584530020 | EQUIA Forte HT Intro (48) A2 - US |
| D6584530010 | EQUIA Forte HT Intro (48) A1 |
| D6584530000 | EQUIA Forte HT Assorted Refill 48 Pack |
| D6584525051 | EQUIA® Forte Coat (50 unit dose & accessories) |
Trademark Results [EQUIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EQUIA 85212947 4122766 Live/Registered |
GC Corporation 2011-01-07 |
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