G2-Bond Universal 013652
GUDID D0470136521
G2-Bond Universal 2-Bond Refill 5ml
Gc America Inc.
Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set| Primary Device ID | D0470136521 |
| NIH Device Record Key | bacd6027-9361-43d9-bf8e-37c97ef17edd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G2-Bond Universal |
| Version Model Number | 013652 |
| Catalog Number | 013652 |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *If not in use for a prolonged period of time, store in refrigerator. |
| Storage Environment Temperature | Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0470136521 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200682
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 | 2021-07-29 |
| Device Publish Date | 2021-07-21 |
On-Brand Devices [G2-Bond Universal]
| D0470136521 | G2-Bond Universal 2-Bond Refill 5ml |
| D0470136511 | G2-Bond Universal 1-Primer Refill 5ml |
| D0470136461 | G2-Bond Universal Bottle Kit |
| D0470136580 | G2-Bond Unvsl 2-Bond Btl Cover 50pk |
| D0470136570 | G2-Bond Unvsl 1-Primer Btl Cover 50pk |
Trademark Results [G2-Bond Universal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 G2-BOND UNIVERSAL 79306350 not registered Live/Pending |
GC Corporation 2020-12-25 |
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