FIT CHECKER™ BLUE 004905
GUDID 14548161297264
FIT CHECKER™Advanced BLUE Cartridge Package (2 x 48 mL cartridges, 6 x mixing tips)
Gc America Inc.
Silicone dental impression material| Primary Device ID | 14548161297264 |
| NIH Device Record Key | 791296fe-6c67-4601-bb2e-fa047f934dd1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FIT CHECKER™ BLUE |
| Version Model Number | 004905 |
| Catalog Number | 004905 |
| 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 | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
| Storage Environment Temperature | Between 73 Degrees Fahrenheit and 0 |
| Storage Environment Temperature | Between 23 Degrees Celsius and 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14548161297264 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120521
FDA Product Code
| ELW | MATERIAL, IMPRESSION |
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 | 2022-08-15 |
| Device Publish Date | 2022-08-05 |
Devices Manufactured by Gc America Inc.
| 14550565002269 - Cytrans Granules | 2026-03-11 Cytrans Granules L 0.5g 1pc |
| 14550565002276 - Cytrans Granules | 2026-03-11 Cytrans Granules L 2.0g 1pc |
| D047014615 - Cytrans Granules | 2026-03-11 Cytrans Granules L 0.5g 1pc |
| D047014616 - Cytrans Granules | 2026-03-11 Cytrans Granules L 2.0g 1pc |
| D6581200012 - COE ALGINATE™ | 2026-01-21 COE ALGINATE™ Normal set, mint, 1 x 1lb powder and 1 x scoop |
| D6581200051 - COE ALGINATE™ | 2026-01-21 COE ALGINATE™ Normal set, mint, 1 x 5lb powder and 1 x scoop |
| D6581200251 - COE ALGINATE™ | 2026-01-21 COE ALGINATE™ Normal set, mint, 5 x 5lb powder (25lb total) |
| D6581201012 - COE ALGINATE™ | 2026-01-21 COE ALGINATE™ Fast set, mint, 1 x 1lb powder and 1 x scoop |
Trademark Results [FIT CHECKER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIT CHECKER 86076203 4741048 Live/Registered |
GC CORPORATION 2013-09-26 |
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