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 ID04548161291340
NIH Device Record Key6d95239f-99eb-4d2d-8459-fd47ca0d91e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameKALORE™
Version Model Number003619
Catalog Number003619
Company DUNS005473608
Company NameGc America Inc.
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com

Device Dimensions

Total Volume0.16 Milliliter
Total Volume0.16 Milliliter
Total Volume0.16 Milliliter
Total Volume0.16 Milliliter
Total Volume0.16 Milliliter
Total Volume0.16 Milliliter
Total Volume0.16 Milliliter
Total Volume0.16 Milliliter
Total Volume0.16 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104548161291340 [Unit of Use]
GS114548161291347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, tooth shade, resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-15
Device Publish Date2022-08-05

On-Brand Devices [KALORE™]

14548161322812KALORE™ Trial Kit (3 syringes - A1, A2, BW) 4g, 2mL each
04548161322808KALORE™ Trial Kit (20 unitips of each: A1, A2. 10 unitips of BW (.16mL each)
04548161293344KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips AO4
04548161293337KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips AO3
04548161293320KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips AO2
14548161293310KALORE™ Syringes (2 mL/4 g) CVT
14548161293303KALORE™ Syringes (2 mL/4 g) GT
14548161293297KALORE™ Syringes (2 mL/4 g) NT
14548161293280KALORE™ Syringes (2 mL/4 g) CT
14548161293273KALORE™ Syringes (2 mL/4 g) DT
14548161293266KALORE™ Syringes (2 mL/4 g) WT
14548161293259KALORE™ Syringes (2 mL/4 g) XBW
14548161293242KALORE™ Syringes (2 mL/4 g) BW
14548161293235KALORE™ Syringes (2 mL/4 g) CVD
14548161293228KALORE™ Syringes (2 mL/4 g) CV
14548161293211KALORE™ Syringes (2 mL/4 g) D2
14548161293204KALORE™ Syringes (2 mL/4 g) C3
14548161293198KALORE™ Syringes (2 mL/4 g) C2
14548161293181KALORE™ Syringes (2 mL/4 g) B3
14548161293174KALORE™ Syringes (2 mL/4 g) B2
14548161293167KALORE™ Syringes (2 mL/4 g) B1
14548161293150KALORE™ Syringes (2 mL/4 g) A4
14548161293143KALORE™ Syringes (2 mL/4 g) A3.5
14548161293136KALORE™ Syringes (2 mL/4 g) A3
14548161293129KALORE™ Syringes (2 mL/4 g) A2
14548161293112KALORE™ Syringes (2 mL/4 g) A1
14548161293105KALORE™ Syringes (2 mL/4 g) OXBW
14548161293099KALORE™ Syringes (2 mL/4 g) OBW
14548161293082KALORE™ Syringes (2 mL/4 g) AO4
14548161293075KALORE™ Syringes (2 mL/4 g) AO3
14548161293068KALORE™ Syringes (2 mL/4 g)AO2
04548161291388KALORE™ Unitip 20 Tips (0.16mL each)
04548161291371KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips C3
04548161291364KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips C2
04548161291357KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips B3
04548161291340KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips B2
04548161291333KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips B1
04548161291326KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips A4
04548161291319KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips A3.5
04548161291302KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips A3
04548161291296KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips A2
04548161291289KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips A1
04548161291272KALORE™ Unitips 10 Tips (0.16mL each) Shade CVT
04548161291265KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips GT
04548161291258KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips NT
04548161291241KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips CT
04548161291234KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips DT
04548161291227KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips WT
04548161291210KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips XBW
04548161291203KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips BW

Trademark Results [KALORE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KALORE
KALORE
98467176 not registered Live/Pending
PINKAVENUE LLC
2024-03-25
KALORE
KALORE
88715071 not registered Live/Pending
Muse by Kendra Randle LLC
2019-12-04
KALORE
KALORE
85438743 4160520 Dead/Cancelled
KALORE INC
2011-10-04
KALORE
KALORE
79111518 not registered Dead/Abandoned
FORET VIERGE SRL
2012-02-23

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