GC Fuji IX GP® 000164
GUDID 24548161282298
GC Fuji IX GP® 6.4 mL liquid btl.
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 Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement| Primary Device ID | 24548161282298 |
| NIH Device Record Key | 1839b4b1-33ab-48fa-85d3-9eebdc925022 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GC Fuji IX GP® |
| Version Model Number | 000164 |
| Catalog Number | 000164 |
| 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 |
| 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 |
Device Dimensions
| Total Volume | 6.4 Milliliter |
| Total Volume | 6.4 Milliliter |
| Total Volume | 6.4 Milliliter |
| Total Volume | 6.4 Milliliter |
| Total Volume | 6.4 Milliliter |
| Total Volume | 6.4 Milliliter |
| Total Volume | 6.4 Milliliter |
| Total Volume | 6.4 Milliliter |
| Total Volume | 6.4 Milliliter |
| Total Volume | 6.4 Milliliter |
| Total Volume | 6.4 Milliliter |
| Total Volume | 6.4 Milliliter |
| Total Volume | 6.4 Milliliter |
Operating and Storage Conditions
| 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 |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14548161282291 [Primary] |
| GS1 | 24548161282298 [Package] Contains: 14548161282291 Package: Carton [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K951555
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 | 2022-08-29 |
| Device Publish Date | 2022-08-19 |
On-Brand Devices [GC Fuji IX GP®]
| 10386040009881 | GC Fuji IX GP® Starter Package, A2 (1 x 15g powder, 1 x 6.4mL liquid, 1 x GC CAVITY CONDITIONER |
| 00386040009099 | GC Fuji IX GP® Capsule (48) Assorted Starter (10 each of A2, A3, A3.5, 9 each of B2 & B3, Capsu |
| 00386040009082 | GC Fuji IX GP® Capsule (48)- B3 |
| 00386040009075 | GC Fuji IX GP® Capsule (48)- B2 |
| 00386040009068 | GC Fuji IX GP® Capsule (48)- A3.5 |
| 00386040009051 | GC Fuji IX GP® Capsule (48)- A3 |
| 00386040009044 | GC Fuji IX GP® Capsule (48)- A2 |
| 00386040009037 | GC Fuji IX GP® Capsule (48) Assorted (10 each of A2, A3, A3.5, 9 each of B2 & B3) |
| 00386040009020 | GC Fuji IX GP® FAST Capsule (48) Assorted Starter (10 each of A2, A3, A3.5, 9 each of B2 & B3, |
| 00386040009013 | GC Fuji IX GP® FAST Capsule (48)-A1 |
| 00386040009006 | GC Fuji IX GP® FAST Capsule (48)- B3 |
| 00386040008993 | GC Fuji IX GP® FAST Capsule (48)- B2 |
| 00386040008986 | GC Fuji IX GP® FAST Capsule (48)- A3.5 |
| 00386040008979 | GC Fuji IX GP® FAST Capsule (48)- A3 |
| 00386040008962 | GC Fuji IX GP® FAST Capsule (48)- A2 |
| 00386040008955 | GC Fuji IX GP® FAST Capsule (48) Assorted (10 each of A2, A3, A3.5, 9 each of B2 & B3) |
| 00386040008948 | GC Fuji IX GP® EXTRA Capsule (48) Assorted Starter (10 each of A2, A3,A3.5, 9 each of B1 & B3, |
| 00386040008931 | GC Fuji IX GP® EXTRA Capsule (48) - C4 |
| 00386040008924 | GC Fuji IX GP® EXTRA Capsule (48) - B3 |
| 00386040008917 | GC Fuji IX GP® EXTRA Capsule (48) - B2 |
| 00386040008900 | GC Fuji IX GP® EXTRA Capsule (48) - B1 |
| 00386040008894 | GC Fuji IX GP® EXTRA Capsule (48)- A3.5 |
| 00386040008887 | GC Fuji IX GP® EXTRA Capsule (48) - A3 |
| 00386040008870 | GC Fuji IX GP® EXTRA Capsule (48) - A2 |
| 00386040008863 | GC Fuji IX GP® EXTRA Capsule (48)- A1 |
| 00386040008856 | GC Fuji IX GP® EXTRA Assorted Pkg Capsule (48) (10 each of A2 A3,A3.5, 9 each of B1 & B3) |
| 24548161329634 | GC Fuji IX GP® Intro Package, 1-1 Pack,1 btl. Powder, Shade A2 (15g) 1 btl liquid (6.4ml), mixi |
| 24548161282328 | GC Fuji IX GP® A2, 15 g powder |
| 24548161282298 | GC Fuji IX GP® 6.4 mL liquid btl. |
Trademark Results [GC Fuji IX GP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GC FUJI IX GP 77400747 3614636 Live/Registered |
GC Corporation 2008-02-19 |
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