KALORE™ 003619
GUDID 04548161291340
KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips B2
Gc America Inc.
Dental composite resin| Primary Device ID | 04548161291340 |
| NIH Device Record Key | 6d95239f-99eb-4d2d-8459-fd47ca0d91e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KALORE™ |
| Version Model Number | 003619 |
| Catalog Number | 003619 |
| Company DUNS | 005473608 |
| Company Name | Gc America Inc. |
| Device Count | 20 |
| 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 | true |
| 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 |
Device Dimensions
| Total Volume | 0.16 Milliliter |
| Total Volume | 0.16 Milliliter |
| Total Volume | 0.16 Milliliter |
| Total Volume | 0.16 Milliliter |
| Total Volume | 0.16 Milliliter |
| Total Volume | 0.16 Milliliter |
| Total Volume | 0.16 Milliliter |
| Total Volume | 0.16 Milliliter |
| Total Volume | 0.16 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04548161291340 [Unit of Use] |
| GS1 | 14548161291347 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K082434
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 [KALORE™]
| 14548161322812 | KALORE™ Trial Kit (3 syringes - A1, A2, BW) 4g, 2mL each |
| 04548161322808 | KALORE™ Trial Kit (20 unitips of each: A1, A2. 10 unitips of BW (.16mL each) |
| 04548161293344 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips AO4 |
| 04548161293337 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips AO3 |
| 04548161293320 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips AO2 |
| 14548161293310 | KALORE™ Syringes (2 mL/4 g) CVT |
| 14548161293303 | KALORE™ Syringes (2 mL/4 g) GT |
| 14548161293297 | KALORE™ Syringes (2 mL/4 g) NT |
| 14548161293280 | KALORE™ Syringes (2 mL/4 g) CT |
| 14548161293273 | KALORE™ Syringes (2 mL/4 g) DT |
| 14548161293266 | KALORE™ Syringes (2 mL/4 g) WT |
| 14548161293259 | KALORE™ Syringes (2 mL/4 g) XBW |
| 14548161293242 | KALORE™ Syringes (2 mL/4 g) BW |
| 14548161293235 | KALORE™ Syringes (2 mL/4 g) CVD |
| 14548161293228 | KALORE™ Syringes (2 mL/4 g) CV |
| 14548161293211 | KALORE™ Syringes (2 mL/4 g) D2 |
| 14548161293204 | KALORE™ Syringes (2 mL/4 g) C3 |
| 14548161293198 | KALORE™ Syringes (2 mL/4 g) C2 |
| 14548161293181 | KALORE™ Syringes (2 mL/4 g) B3 |
| 14548161293174 | KALORE™ Syringes (2 mL/4 g) B2 |
| 14548161293167 | KALORE™ Syringes (2 mL/4 g) B1 |
| 14548161293150 | KALORE™ Syringes (2 mL/4 g) A4 |
| 14548161293143 | KALORE™ Syringes (2 mL/4 g) A3.5 |
| 14548161293136 | KALORE™ Syringes (2 mL/4 g) A3 |
| 14548161293129 | KALORE™ Syringes (2 mL/4 g) A2 |
| 14548161293112 | KALORE™ Syringes (2 mL/4 g) A1 |
| 14548161293105 | KALORE™ Syringes (2 mL/4 g) OXBW |
| 14548161293099 | KALORE™ Syringes (2 mL/4 g) OBW |
| 14548161293082 | KALORE™ Syringes (2 mL/4 g) AO4 |
| 14548161293075 | KALORE™ Syringes (2 mL/4 g) AO3 |
| 14548161293068 | KALORE™ Syringes (2 mL/4 g)AO2 |
| 04548161291388 | KALORE™ Unitip 20 Tips (0.16mL each) |
| 04548161291371 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips C3 |
| 04548161291364 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips C2 |
| 04548161291357 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips B3 |
| 04548161291340 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips B2 |
| 04548161291333 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips B1 |
| 04548161291326 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips A4 |
| 04548161291319 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips A3.5 |
| 04548161291302 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips A3 |
| 04548161291296 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips A2 |
| 04548161291289 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips A1 |
| 04548161291272 | KALORE™ Unitips 10 Tips (0.16mL each) Shade CVT |
| 04548161291265 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips GT |
| 04548161291258 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips NT |
| 04548161291241 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips CT |
| 04548161291234 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips DT |
| 04548161291227 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips WT |
| 04548161291210 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips XBW |
| 04548161291203 | KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips BW |
Trademark Results [KALORE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KALORE 98467176 not registered Live/Pending |
PINKAVENUE LLC 2024-03-25 |
 KALORE 88715071 not registered Live/Pending |
Muse by Kendra Randle LLC 2019-12-04 |
 KALORE 85438743 4160520 Dead/Cancelled |
KALORE INC 2011-10-04 |
 KALORE 79111518 not registered Dead/Abandoned |
FORET VIERGE SRL 2012-02-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.