G-CEM LinkAce™ 002903

GUDID 04548161330230

G-CEM LinkAce™ 10 x GC Automix Tips for Endo

Gc America Inc.

Silicone dental impression material

• Primary Device ID: 04548161330230
• NIH Device Record Key: 167ee73b-998d-46a3-89ad-5aaaf7a1feb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-CEM LinkAce™
• Version Model Number: 002903
• Catalog Number: 002903
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04548161330230 [Unit of Use]
GS1	14548161330237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061535

FDA Product Code

• EMA: CEMENT, DENTAL

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-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