G-CEM LinkForce™ 009541
GUDID 44548161321830
G-CEM LinkForce™ System Kit 3 LinkForce syringes (8.7g) one each of A2, Translucent Opaque, 45 regular mixing tips, 5 endo mixing tips with intraoral tip, 1 btl. G-Premio Bond 5mL, 1 btl G-Multi Primer 5mL, 1 btl G-Premio Bond DCA 3mL, 1 syringe GC Etchant 4.8g, 25 dispensing tips+2 covers (for GC Etchant & Try-in Paste), 3 syringe GC Try-in Paste (A2, Translucent, Opaque), 50 disposable applicator, 20 disposable dispensing dish
Gc America Inc.
Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin| Primary Device ID | 44548161321830 |
| NIH Device Record Key | 4a05a0eb-708f-4f1f-895a-4b8c43948b39 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G-CEM LinkForce™ |
| Version Model Number | 009541 |
| Catalog Number | 009541 |
| 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 | |
| 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
| Special Storage Condition, Specify | Between 0 and 0 *Store in refrigerator |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in refrigerator |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in refrigerator |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in refrigerator |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in refrigerator |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in refrigerator |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in refrigerator |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in refrigerator |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in refrigerator |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in refrigerator |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in refrigerator |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in refrigerator |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in refrigerator |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Special Storage Condition, Specify |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14548161321839 [Primary] |
| GS1 | 44548161321830 [Package] Contains: 14548161321839 Package: Carton [8 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153231
FDA Product Code
| EMA | CEMENT, DENTAL |
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 | 2022-08-29 |
| Device Publish Date | 2022-08-19 |
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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