GC TEMP ADVANTAGE® 136506

GUDID 00386040005138

GC TEMP ADVANTAGE® 15 x mixing tips

Gc America Inc.

Silicophosphate dental cement Silicophosphate dental cement Silicophosphate dental cement Silicophosphate dental cement Silicophosphate dental cement Silicophosphate dental cement Silicophosphate dental cement Silicophosphate dental cement 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)