GC Fuji® 444002
GUDID 10386040012515
GC Fuji® Automix LC Starter Set A2, Paste Pak Dispenser II, Cavity conditioner
Gc America Inc.
Glass ionomer dental cement| Primary Device ID | 10386040012515 |
| NIH Device Record Key | b29831c5-6528-48d9-9652-f9788bf3e6ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GC Fuji® |
| Version Model Number | 444002 |
| Catalog Number | 444002 |
| 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 |
Device Dimensions
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
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 | 10386040012515 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172382
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 | 2022-07-25 |
| Device Publish Date | 2022-07-15 |
On-Brand Devices [GC Fuji®]
| 10386040012522 | GCFuji® Automix LC Starter Set A3, Paste Pak Dispenser II, Cavity conditioner |
| 10386040012515 | GC Fuji® Automix LC Starter Set A2, Paste Pak Dispenser II, Cavity conditioner |
| 10386040012508 | GC Fuji® Automix LC Starter Set A1, Paste Pak Dispenser II, Cavity conditioner |
| 14548161321983 | GC Fuji® Automix LC Set - Cartridge A3 shade + 20 Automix tips |
| 14548161321976 | GC Fuji® Automix LC Set - Cartridge A2 shade + 20 Automix tips |
| 14548161321969 | GC Fuji® Automix LC Set- Cartridge A1 shade + 20 Automix tips |
Trademark Results [GC Fuji]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GC FUJI 86353566 4699637 Live/Registered |
Trademark Holdings of Illinois LLC 2014-07-31 |
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