GRADIA® 002596

GUDID 04548161292194

GRADIA® DIRECT X Unitip 10 tips (3g/16mL) -X-AO2

Gc America Inc.

Dental composite resin
Primary Device ID04548161292194
NIH Device Record Key0689a8e4-6d80-475e-9965-b0f00d4e06e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameGRADIA®
Version Model Number002596
Catalog Number002596
Company DUNS005473608
Company NameGc America Inc.
Device Count10
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 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
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104548161292194 [Unit of Use]
GS114548161292191 [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 [GRADIA®]

10386040008488GRADIA® Complete System (1CORE Kit, 1 GC FIBER POST Assortment Kit, 1CORE Cartridge Dispenser)
10386040008471GRADIA® CORE Dispensing Gun, 1 piece
10386040008464GRADIA® GC FIBER POST Drill Refills, Contains: 1 drill of one size, Diameter 1.6
10386040008457GRADIA® GC FIBER POST Drill Refills, 1 drill of one size, Diameter 1.4
10386040008440GRADIA® GC FIBER POST Drill Refills, 1 drill of one size, Diameter 1.2
00386040008436GRADIA® GC FIBER POST Refills, 10 posts of one size Diameter 1.6
00386040008429GRADIA® GC FIBER POST Refills, 10 posts of one size, Diameter 1.4
00386040008412GRADIA® GC FIBER POST Refills Contains: 10 posts of one size Diameter 1.2
00386040008405GRADIA® GC FIBER POST Refills Contains: 10 posts of one size Diameter 1.0
00386040008399GRADIA® GC FIBER POST Refills Contains: 10 posts of one size-diameter 0.8
00386040008382GRADIA® GC FIBER POST Assortment Kit Contains: 5 Posts each-diameter 1.2, 1.4, 1.6, 1 Drill ea
14548161393294GRADIA® gum Fiber (GF7), 1.4 g
14548161393287GRADIA® gum Translucent (GT41), 2.2 mL
14548161393270GRADIA® gum Modifier (GM36), 2.4 mL
14548161393263GRADIA® gum Modifier (GM35), 2.4 mL
14548161393256GRADIA® gum Modifier (GM34), 2.4 mL
14548161393249GRADIA® gum Modifier (GM33), 2.4 mL
14548161393232GRADIA® gum Modifier (GM32), 2.4 mL
14548161393225GRADIA® gum Modifier (GM31), 2.4 mL
14548161393218GRADIA® gum Modifier (GM30), 2.4 mL
14548161393201GRADIA® gum Modifier (G244), 2.9 mL
14548161393195GRADIA® gum (G23), 2.9 mL
14548161393188GRADIA® gum Opaque (GO22), 2.9 mL
14548161393171GRADIA® gum (G21), 2.9 mL
14548161393164GRADIA® gum Opaque (GO20), 2.9 mL
14548161393157GRADIA® gum Opaque Modifier (GOM51)
14548161393140GRADIA® gum Opaque (GO13), 2.4 mL
14548161393133GRADIA® gum Opaque (GO12), 2.4 mL
14548161393126GRADIA® gum Opaque (GO11), 2.4 mL
14548161393119GRADIA® gum Starter Package Contains: Two opaques (2.4 mL syringes), 4 shades (2.9 mL syringes)
14548161393058GRADIA® DIAMOND POLISHER 8G
14548161393041GRADIA® MAMELON STAINS MS5
14548161393034GRADIA® MAMELON STAIN MS3
14548161393027GRADIA® MAMELON STAIN MS2
14548161393010GRADIA® INTENSIVE COLOR IC14
14548161393003GRADIA® INTENSIVE COLOR IC13
14548161392990GRADIA® INTENSIVE COLOR IC12
14548161392983GRADIA® INTENSIVE COLOR IC11
14548161392976GRADIA® INTENSIVE COLOR IC10
14548161392969GRADIA® INTENSIVE COLOR IC9
14548161392952GRADIA® INTENSIVE COLOR IC8
14548161392945GRADIA® INTENSIVE COLOR IC7
14548161392938GRADIA® INTENSIVE COLOR IC6
14548161392921GRADIA® INTENSIVE COLOR IC5
14548161392914GRADIA® INTENSIVE COLOR IC4
14548161392907GRADIA® INTENSIVE COLOR IC3
14548161392891GRADIA® INTENSIVE COLOR IC2
14548161392884GRADIA® INTENSIVE COLOR IC1
14548161392877GRADIA® INTENSIVE COLOR IC0
14548161392860GRADIA® CERVICAL TRANSLUCENT CT4

Trademark Results [GRADIA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GRADIA
GRADIA
76413645 2693105 Live/Registered
GC Corporation
2002-05-30
GRADIA
GRADIA
75713250 not registered Dead/Abandoned
GC Corporation
1999-05-24
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