G-aenial™ 012353

GUDID D0470123530

G-aenial Univ. Injectable Unitip 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: D0470123530
• NIH Device Record Key: b1d723b4-3394-4aeb-bfe6-495edb0680de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-aenial™
• Version Model Number: 012353
• Catalog Number: 012353
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 15
• 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

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
HIBCC	D0470123530 [Unit of Use]
HIBCC	D0470123531 [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: 2021-08-30
• Device Publish Date: 2021-08-20

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)