| Primary Device ID | D0470119471 |
| NIH Device Record Key | bda2b6bf-44cf-4391-98e3-55178ee272f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G-aenial™ Bond |
| Version Model Number | 011947 |
| Catalog Number | 011947 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 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 |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Storage Environment Temperature | Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 1 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 1 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 1 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 1 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 1 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 1 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 1 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 1 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 1 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 1 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 1 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 1 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 34 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 1 Degrees Celsius and 28 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0470119471 [Primary] |
| KLE | AGENT, TOOTH BONDING, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-02-16 |
| Device Publish Date | 2017-09-01 |
| 14548161296526 | G-aenial™ Bond (1 x 5 mL bottle) Refill |
| 14548161296489 | G-aenial™ Bond Starter Kit (1 x 5 mL bottle, 50 x disposable applicators (fine), 20 x disposab |
| 14548161282826 | G-aenial™ Bond (1 x 5 mL bottle) |
| 14548161282628 | G-aenial™ Bond Starter Kit (1 x 5 mL bottle, 50 x disposable applicators (fine), 20 x disposab |
| D0470119471 | G-aenial™ Bond (1 x 5 mL bottle) Refill |
| D0470119421 | G-aenial™ Bond Starter Kit (1 x 5 mL bottle, 50 x disposable applicators (fine), 20 x disposab |
| D0470042201 | G-aenial™ Bond (1 x 5 mL bottle) |
| D0470042171 | G-aenial™ Bond Starter Kit (1 x 5 mL bottle, 50 x disposable applicators (fine), 20 x disposab |