G-Bond ™ 002302
GUDID 04548161075667
G-Bond ™ Starter Kit, Unit Dose (50 x 0.1 mL unit doses & 50 x disposable applicators)
Gc America Inc.
Dentine bonding agent/set| Primary Device ID | 04548161075667 |
| NIH Device Record Key | 83588a59-285d-4f9f-afca-49bcb390b212 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G-Bond ™ |
| Version Model Number | 002302 |
| Catalog Number | 002302 |
| Company DUNS | 005473608 |
| Company Name | Gc America Inc. |
| Device Count | 50 |
| 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 | true |
| 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
Device Dimensions
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
Operating and Storage Conditions
| 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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04548161075667 [Unit of Use] |
| GS1 | 14548161075664 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041471
FDA Product Code
| KLE | AGENT, TOOTH BONDING, RESIN |
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 | 2022-10-19 |
| Device Publish Date | 2022-10-11 |
On-Brand Devices [G-Bond ™]
| 14548161074728 | G-Bond ™ Starter Kit, Bottle (1 x 5 mL bottle, 50 x disposable applicators & 1 x dispenser tra |
| 04548161075667 | G-Bond ™ Starter Kit, Unit Dose (50 x 0.1 mL unit doses & 50 x disposable applicators) |
| D0470023021 | G-Bond ™ Starter Kit, Unit Dose (50 x 0.1 mL unit doses & 50 x disposable applicators) |
| D0470022771 | G-Bond ™ Starter Kit, Bottle (1 x 5 mL bottle, 50 x disposable applicators & 1 x dispenser tra |
Trademark Results [G-Bond]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 G-BOND 98526815 not registered Live/Pending |
XXENTRIA TECHNOLOGY MATERIALS CO., LTD. 2024-04-30 |
 G-BOND 85786246 4367974 Live/Registered |
Xxentria International LLC 2012-11-23 |
 G-BOND 78798656 not registered Dead/Abandoned |
Xxentria International USA 2006-01-25 |
 G-BOND 78478572 3262057 Live/Registered |
GC Corporation 2004-09-03 |
 G-BOND 74462208 not registered Dead/Abandoned |
Huntsman Film Products Corp. 1993-11-23 |
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