G-CEM LinkAce™ 004860

GUDID D0470048601

G-CEM LinkAce™ BO1, 2 x syringes, 15 GC Automix Tips, 5 x GC Automix Tips for Endo

Gc America Inc.

Dental composite resin

• Primary Device ID: D0470048601
• NIH Device Record Key: 7024e125-85a3-42ab-b845-a945f98a887e
• Commercial Distribution Discontinuation: 2021-08-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-CEM LinkAce™
• Version Model Number: 004860
• Catalog Number: 004860
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 1
• 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
• 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 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 8 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0470048601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120243

FDA Product Code

• EMA: CEMENT, DENTAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-30
• Device Publish Date: 2016-08-01

On-Brand Devices [G-CEM LinkAce™]

• D0470048601: G-CEM LinkAce™ BO1, 2 x syringes, 15 GC Automix Tips, 5 x GC Automix Tips for Endo
• D0470048591: G-CEM LinkAce™ AO3, 2 x syringes, 15 GC Automix Tips, 5 x GC Automix Tips for Endo
• D0470048581: G-CEM LinkAce™ Translucent, 2 x syringes, 15 GC Automix Tips, 5 x GC Automix Tips for Endo
• D0470048571: G-CEM LinkAce™ A2, 2 x syringes (4.6g) 15 GC Automix Tips,
• 04548161330230: G-CEM LinkAce™ 10 x GC Automix Tips for Endo
• 04548161330223: G-CEM LinkAce™ 20 x GC Automix Tips