KALORE™ 003613
GUDID 04548161291289
KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips A1
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| Primary Device ID | 04548161291289 |
| NIH Device Record Key | 7242692b-eaf9-4336-8be1-ccad74c6b44c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KALORE™ |
| Version Model Number | 003613 |
| Catalog Number | 003613 |
| 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 | 04548161291289 [Unit of Use] |
| GS1 | 14548161291286 [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 |
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