GC TEMP ADVANTAGE® 136506

GUDID 00386040005138

GC TEMP ADVANTAGE® 15 x mixing tips

Gc America Inc.

Silicophosphate dental cement

• Primary Device ID: 00386040005138
• NIH Device Record Key: 2b9f3dee-1896-4b83-808f-4f759f6f579b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC TEMP ADVANTAGE®
• Version Model Number: 136506
• Catalog Number: 136506
• 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: 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	00386040005138 [Unit of Use]
GS1	10386040005135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023727

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: 2022-07-15
• Device Publish Date: 2022-07-07

On-Brand Devices [GC TEMP ADVANTAGE®]

• 10386040005142: GC TEMP ADVANTAGE® Bulk Package (4 x 7.5g syringes)
• 00386040005138: GC TEMP ADVANTAGE® 15 x mixing tips
• 10386040005128: GC TEMP ADVANTAGE® Starter Package (1 x 7.5g syringe and 15 x mixing tips)