G-CEM LinkForce™ 012806
GUDID 14548161292504
G-CEM Try-In Paste Bleach Refill Syringe, 3 disensing tips (metal type), 1 tip cover
Gc America Inc.
Dental cement trial| Primary Device ID | 14548161292504 |
| NIH Device Record Key | 81019b9e-6e37-4546-bb82-c149bebb7c1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G-CEM LinkForce™ |
| Version Model Number | 012806 |
| Catalog Number | 012806 |
| 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 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 |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14548161292504 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153231
FDA Product Code
| EBF | Material, tooth shade, 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 | 2022-08-15 |
| Device Publish Date | 2022-08-05 |
On-Brand Devices [G-CEM LinkForce™]
| D0470095514 | G-CEM LinkForce™ Try-In Paste Bleach, 1 syringe (1.5g/1.2mL) |
| D0470095504 | G-CEM LinkForce™ Try-In Paste Opaque 1 syringe (1.5g/1.2mL) |
| D0470095494 | G-CEM LinkForce™ Try-In Paste Translucent 1 syringe (1.5g/1.2mL) |
| D0470095484 | G-CEM Link Force™ Try-In Paste A2, 1 syringe (1.5g/1.2mL) |
| 14548161292504 | G-CEM Try-In Paste Bleach Refill Syringe, 3 disensing tips (metal type), 1 tip cover |
| 14548161292498 | G-CEM Try-In Paste Opaque Refill Syringe, 3 dispensing tips (metal type), 1 tip cover |
| 14548161292481 | G-CEM Try-In Paste Translucent Refill Syringe, 3 Dispensing tips (metal type) 1 tip cover |
| 14548161292474 | G-CEM Try-In Paste A2 Refill Syringe, 3 dispensing tips (metal type), 1 tip cover |
| 44548161321892 | G-CEM LinkForce™ Cement Refill Bleach, 1 syringe (8.7g/5mL) 20 regular mixing tips |
| 44548161321885 | G-CEM LinkForce™ Cement Refill Opaque, 1 syringe (8.7g/5mL), 20 regular mixing tips |
| 44548161321878 | G-CEM LinkForce™ Cement Refill Translucent, 1 syringe (8.7g/5mL), 20 regular mixing tips |
| 44548161321861 | G-CEM LinkForce™ Cement Refill A2, 1 syringe (8.7g/5mL), 20 regular mixing tips |
| 44548161321854 | G-CEM LinkForce™ Starter Kit Translucent, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5 |
| 44548161321847 | G-CEM LinkForce™ Starter Kit A2, 1 LinkForce syringe (8.7g), 1 bottle G-Premio Bond 5mL, 1 bot |
| 44548161321830 | G-CEM LinkForce™ System Kit 3 LinkForce syringes (8.7g) one each of A2, Translucent Opaque, 45 |
Trademark Results [G-CEM LinkForce]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 G-CEM LINKFORCE 85754860 5124527 Live/Registered |
GC Corporation 2012-10-16 |
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