G-aenial™ 012378

GUDID 04548161328701

G-aenial Universal Injectable XBW, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10), Light Protective Cap (2)

Gc America Inc.

Dental composite resin

• Primary Device ID: 04548161328701
• NIH Device Record Key: b2ba97ef-5e4c-4df4-ad75-d1359f8f9d86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-aenial™
• Version Model Number: 012378
• Catalog Number: 012378
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 2
• 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: false
• 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: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 Milliliter
• Total Volume: 1 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	04548161328701 [Unit of Use]
GS1	14548161328708 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173500

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 [G-aenial™]

• D0470123630: G-aenial Univ. Injectable Unitip BW
• D0470123620: G-aenial Univ. Injectable Unitip XBW
• D0470123610: G-aenial Univ. Injectable Unitip AE
• D0470123600: G-aenial Univ. Injectable Unitip JE
• D0470123590: G-aenial Univ. Injectable Unitip AO3
• D0470123580: G-aenial Univ. Injectable Unitip AO2
• D0470123570: G-aenial Univ. Injectable Unitip AO1
• D0470123560: G-aenial Univ. Injectable Unitip CVD
• D0470123550: G-aenial Univ. Injectable Unitip CV
• D0470123540: G-aenial Univ. Injectable Unitip B2
• D0470123530: G-aenial Univ. Injectable Unitip B1
• D0470123520: G-aenial Univ. Injectable Unitip A4
• D0470123510: G-aenial Univ. Injectable Unitip A3.5
• D0470123500: G-aenial Univ. Injectable Unitip A3
• D0470123490: G-aenial Univ. Injectable Unitip A2
• D0470123480: G-aenial Univ. Injectable Unitip A1
• 10386040008495: G-aenial™ G-aenial Bond & Universal Flo Intro Kit (1 x 5mL G-aenial Bond kit, 1 x G-aenial Uni
• 04548161337659: Dispensing Tip Long Needle, 20 pcs.
• 04548161331459: G-aenial™ Bond Unit Dose, 50 unit doses
• 14548161328739: G-aenial™ Bulk Injectable A2
• 14548161328722: G-aenial™ Bulk Injectable A1
• 04548161328718: G-aenial Universal Injectable BW, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10), L
• 04548161328701: G-aenial Universal Injectable XBW, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10),
• 04548161328695: G-aenial Universal Injectable AE, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10), L
• 04548161328688: G-aenial Universal Injectable JE, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10), L
• 04548161328671: G-aenial Universal Injectable AO3, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10),
• 04548161328664: G-aenial Universal Injectable AO2, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10),
• 04548161328657: G-aenial Universal Injectable AO1, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10),
• 04548161328640: G-aenial Universal Injectable CVD, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10),
• 04548161328633: G-aenial Universal Injectable CV, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10), L
• 04548161328626: G-aenial Universal Injectable B2, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10), L
• 04548161328619: G-aenial Universal Injectable B1, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10), L
• 04548161328602: G-aenial Universal Injectable A4, Dispensing Tip Needle (10), Dispensing Tip Long Needle (10), L
• 04548161328565: G-aenial Universal Injectable A1, Dispensing Tip Needle (10), DispensingTip Long Needle (10), Li
• 04548161327568: G-aenial™ Sculpt 10 Unitip AE (0.16mL each)
• 04548161327551: G-aenial™ Sculpt 10 Unitip JE (0.16mL each)
• 04548161327544: G-aenial™ Sculpt 10 Unitip CV (0.16mL each)
• 04548161327537: G-aenial™ Sculpt 10 Unitip XBW
• 04548161327520: G-aenial™ Sculpt 10 Unitip BW (0.16mL each)
• 04548161327513: G-aenial™ Sculpt 10 Unitip A03 (0.16mL each)
• 04548161327506: G-aenial™ Sculpt 10 Unitip A02 (0.16mL each)
• 04548161327490: G-aenial™ Sculpt 10 Unitip A01 (0.16mL each)
• 04548161327483: G-aenial™ Sculpt 20 Unitip C3 (0.16mL each)
• 04548161327476: G-aenial™ Sculpt 20 Untip B3 (0.16mL each)
• 04548161327469: G-aenial™ Sculpt 20 Unitip B2 (0.16mL each)
• 04548161327452: G-aenial™ Sculpt 20 Unitip B1 (0.16mL each)
• 04548161327445: G-aenial™ Sculpt 20 Unitip A4 (0.16mL each)
• 04548161327438: G-aenial™ Sculpt 20 Unitip A3.5 (0.16mL each)
• 04548161327421: G-aenial™ Sculpt 20 Unitip A3 (0.16mL each)
• 04548161327414: G-aenial™ Sculpt 20 Unitip A2 (0.16mL each)