GC Fuji PLUS® 431101
GUDID 10386040009164
GC Fuji PLUS® No Etch Package (1 x 15g powder, 1 x 7mL liquid & accessories)
Gc America Inc.
Glass ionomer dental cement| Primary Device ID | 10386040009164 |
| NIH Device Record Key | 7163b8a6-2590-4783-ae2f-f91edf6ce94b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GC Fuji PLUS® |
| Version Model Number | 431101 |
| Catalog Number | 431101 |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10386040009164 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K946100
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 [GC Fuji PLUS®]
| 10386040009164 | GC Fuji PLUS® No Etch Package (1 x 15g powder, 1 x 7mL liquid & accessories) |
| 20386040009154 | GC Fuji PLUS® 7mL liquid |
| 20386040009147 | GC Fuji PLUS® 15g powder |
| 20386040009130 | GC Fuji PLUS® 1:1 Kit (1 x 15g powder, 1 x 7mL liquid, 1 x GC Fuji PLUS CONDITIONER & accessori |
| 00386040008849 | GC Fuji PLUS® Capsule No-Etch Starter Package 48 capsules (0.36g powder; 0.16mL liquid per caps |
| 00386040008832 | GC Fuji PLUS® Capsule Package Quantity of 48 capsules (0.36g powder; 0.16mL liquid per capsule) |
| 24548161283080 | GC Fuji PLUS® Conditioner btl. (6.5 mL) |
Trademark Results [GC Fuji PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GC FUJI PLUS 75108147 2186360 Live/Registered |
TRADEMARK HOLDINGS OF ILLINOIS LLC 1996-05-22 |
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