G-CEM LinkAce™ 004859
GUDID D0470048591
G-CEM LinkAce™ AO3, 2 x syringes, 15 GC Automix Tips, 5 x GC Automix Tips for Endo
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 Dental composite resin Dental composite resin Dental composite resin| Primary Device ID | D0470048591 |
| NIH Device Record Key | 1a8803e1-90ed-42c3-a7bb-c2c340ebb185 |
| Commercial Distribution Discontinuation | 2021-08-01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G-CEM LinkAce™ |
| Version Model Number | 004859 |
| Catalog Number | 004859 |
| 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 | |
| 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 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0470048591 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120243
FDA Product Code
| EMA | CEMENT, DENTAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-07-30 |
| Device Publish Date | 2016-08-01 |
On-Brand Devices [G-CEM LinkAce™]
| D0470048601 | G-CEM LinkAce™ BO1, 2 x syringes, 15 GC Automix Tips, 5 x GC Automix Tips for Endo |
| D0470048591 | G-CEM LinkAce™ AO3, 2 x syringes, 15 GC Automix Tips, 5 x GC Automix Tips for Endo |
| D0470048581 | G-CEM LinkAce™ Translucent, 2 x syringes, 15 GC Automix Tips, 5 x GC Automix Tips for Endo |
| D0470048571 | G-CEM LinkAce™ A2, 2 x syringes (4.6g) 15 GC Automix Tips, |
| 04548161330230 | G-CEM LinkAce™ 10 x GC Automix Tips for Endo |
| 04548161330223 | G-CEM LinkAce™ 20 x GC Automix Tips |
Trademark Results [G-CEM LinkAce]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 G-CEM LINKACE 85754833 4580842 Live/Registered |
GC Corporation 2012-10-16 |
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