GRADIA® 002272

GUDID 04548161075292

GRADIA® DIRECT Unitips: 10 tips - 0.16 mL B1

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: 04548161075292
• NIH Device Record Key: 126c56d3-61f3-4957-860c-74c965a8f265
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRADIA®
• Version Model Number: 002272
• Catalog Number: 002272
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 10
• 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
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: 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 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548161075292 [Unit of Use]
GS1	14548161075299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023814

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 [GRADIA®]

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