TEMPSMART™ 009397
GUDID 24548161316887
TEMPSMART™ 48mL Cartridge BW
Gc America Inc.
Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin| Primary Device ID | 24548161316887 |
| NIH Device Record Key | 63c0e7d9-9f7b-4403-9bc9-fe9538f8d2bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TEMPSMART™ |
| Version Model Number | 009397 |
| Catalog Number | 009397 |
| 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 |
Device Dimensions
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
| Total Volume | 48 Milliliter |
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 |
| 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 | 14548161316880 [Primary] |
| GS1 | 24548161316887 [Package] Contains: 14548161316880 Package: Carton [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141562
FDA Product Code
| EBG | CROWN AND BRIDGE, TEMPORARY, 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 | 2022-08-29 |
| Device Publish Date | 2022-08-19 |
On-Brand Devices [TEMPSMART™]
| D0470094012 | TEMPSMART™ 10mL Cartridge B1 |
| D0470094002 | TEMPSMART™ 10mL Cartridge A3 |
| D0470093992 | TEMPSMART™ 10mL Cartridge A2 |
| D0470093982 | TEMPSMART™ 10mL cartridge A1 |
| D0470093972 | TEMPSMART™ 48mL Cartridge BW |
| D0470093962 | TEMPSMART™ 48mL Cartridge B1 |
| D0470093952 | TEMPSMART™ 48mL Cartridge A3.5 |
| D0470093942 | TEMPSMART™ 48mL Cartridge A3 |
| D0470093932 | TEMPSMART™ 48mL Cartridge A2 |
| D0470093922 | TEMPSMART™ 48mL Cartridge A1 |
| 00386040012495 | TEMPSMART™ 48mL Mixing Tip II SSS (20) |
| 24548161316924 | TEMPSMART™ 10mL Cartridge B1 |
| 24548161316917 | TEMPSMART™ 10mL Cartridge A3 |
| 24548161316900 | TEMPSMART™ 10mL Cartridge A2 |
| 24548161316894 | TEMPSMART™ 10mL cartridge A1 |
| 24548161316887 | TEMPSMART™ 48mL Cartridge BW |
| 24548161316870 | TEMPSMART™ 48mL Cartridge B1 |
| 24548161316863 | TEMPSMART™ 48mL Cartridge A3.5 |
| 24548161316856 | TEMPSMART™ 48mL Cartridge A3 |
| 24548161316849 | TEMPSMART™ 48mL Cartridge A2 |
| 24548161316825 | TEMPSMART™ 48mL Cartridge A1 |
Trademark Results [TEMPSMART]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TEMPSMART 86721437 5009429 Live/Registered |
GC Corporation 2015-08-11 |
 TEMPSMART 78511947 3083803 Live/Registered |
ZINUS INC. 2004-11-05 |
 TEMPSMART 77562833 3854348 Live/Registered |
NYKO TECHNOLOGIES, INC. 2008-09-04 |
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