GC Fuji ORTHO™ 439451

GUDID 00386040009808

GC Fuji ORTHO™ LC Starter Package (50 x capsules - (mixed volume per capsule 0.10mL), 1 x GC ORTHO CONDITIONER, 1 x Capsule Applier)

Gc America Inc.

Glass ionomer dental cement

• Primary Device ID: 00386040009808
• NIH Device Record Key: 504d8e0b-33f9-4a70-8325-df91224f6925
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC Fuji ORTHO™
• Version Model Number: 439451
• Catalog Number: 439451
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 50
• 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

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	00386040009808 [Unit of Use]
GS1	10386040009805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981461

FDA Product Code

• DYH: ADHESIVE, BRACKET AND TOOTH CONDITIONER, 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: 2022-07-21
• Device Publish Date: 2022-07-13

On-Brand Devices [GC Fuji ORTHO™]

• D6584394871: GC Fuji ORTHO™ LC Automix Starter set (1 x 13.3g (7.2mL) Cartridge, 1 x GC Paste Pak Dispenser
• D0470031051: GC Fuji ORTHO™ (2 x 13.3 g (7.2 mL) Cartridge, 1 x mixing pad)
• D0470031021: GC Fuji ORTHO™ Automix set (1 x 13.3 g (7.2 mL) Cartridge, 20 x GC Mixing Tip For LC, 2 x 1.4
• D6584394661: GC Fuji ORTHO™ Band LC Automix Starter Set (2 x 13.3g (7.2mL) Cartridge, 1 x GC Paste Pak Disp
• D6584230081: GC Fuji ORTHO™ Mixing Tip for LC, 20 pieces
• D0470031031: GC Fuji ORTHO™ (2 x 13.3 g (7.2 mL) Cartridge, 1 x mixing pad)
• D0470135731: Fuji Ortho Band LC Paste Pak SL
• D0470135721: Ortho LC Paste Pak Automix Refill SL
• D0470135711: FUJI Ortho LC Paste Pak Automix Set SL
• 20386040009864: GC Fuji ORTHO™ Intro Package, 1-2 Pack (1 x 40g powder, 2 x 6.8mL liquid & accessories)
• 10386040009843: GC Fuji ORTHO™ LC Automix Starter set (1 x 13.3g (7.2mL) Cartridge, 1 x GC Paste Pak Dispenser
• 10386040009836: GC Fuji ORTHO™ Band LC Automix Starter Set (2 x 13.3g (7.2mL) Cartridge, 1 x GC Paste Pak Disp
• 10386040009829: GC Fuji ORTHO™ Band (Paste Pak) Starter Package (2 x 13.3 g (7.2mL) cartridges, 1 x mixing pad
• 00386040009808: GC Fuji ORTHO™ LC Starter Package (50 x capsules - (mixed volume per capsule 0.10mL), 1 x GC O
• 20386040009796: GC Fuji ORTHO™ LC Box of 50 capsules (mixed volume per capsule 0.10mL)
• 20386040009697: GC Fuji ORTHO™ LC Standard Package (1 x 40g powder, 2 x 6.8mL liquid, 1 x scoop & 1 x mixing p
• 20386040009680: GC Fuji ORTHO™ LC Introductory Package (1 x 15g powder, 1 x 6.8mL liquid, 1 x scoop & 1 x mixi
• 00386040008658: GC Fuji ORTHO™ Mixing Tip for LC, 20 pieces
• 14548161293952: GC Fuji ORTHO™ (2 x 13.3 g (7.2 mL) Cartridge, 1 x mixing pad)
• 14548161293938: GC Fuji ORTHO™ (2 x 13.3 g (7.2 mL) Cartridge, 1 x mixing pad)
• 14548161293921: GC Fuji ORTHO™ Automix set (1 x 13.3 g (7.2 mL) Cartridge, 20 x GC Mixing Tip For LC, 2 x 1.4
• 14548161072632: GC Fuji ORTHO™ (2 x 13.3 g (7.2 mL) cartridges & 1 x mixing pad)
• 14548161072601: GC Fuji ORTHO™ CONDITIONER, 25g (23.8 mL) liquid
• 24548161293683: GC Fuji ORTHO™ (6.8 mL) liquid btl
• 24548161293676: GC Fuji ORTHO™ 40 g powder btl
• 24548161283240: GC Fuji ORTHO™ 8g (6.8 mL) liquid
• 24548161283035: GC Fuji ORTHO™ 40 g powder
• 14548161332002: Fuji Ortho Band LC Paste Pak SL
• 14548161331999: Ortho LC Paste Pak Automix Refill SL
• 14548161331982: FUJI Ortho LC Paste Pak Automix Set SL
• 10386040015288: 10006624
• 10386040015271: 10006622
• 10386040015264: 10006623