everStick® 900831

GUDID 15400556008680

everStick® ORTHO 2 x 12 cm fiber bundles

Gc America Inc.

Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre Dental reinforcing fibre

• Primary Device ID: 15400556008680
• NIH Device Record Key: 537fd476-a787-431f-9cc2-9477a8986d50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: everStick®
• Version Model Number: 900831
• Catalog Number: 900831
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15400556008680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021126

FDA Product Code

• EBI: RESIN, DENTURE, RELINING, REPAIRING, REBASING

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: 2022-08-08
• Device Publish Date: 2022-07-29

On-Brand Devices [everStick®]

• J0229008221: everStick® PERIO 2 x 12 cm fiber bundles
• J0229008271: everStick® POST Intro Kit (5 x 0.9 posts, 5 x 1.2 posts and 5 x 1.5 posts and 1 x 5 mL of Stick
• J0229008191: everSticks Starter Kit
• 15400556008710: everStick® 1 x 8 cm fiber bundle (everStickC&B)
• 15400556008703: everStick® C&B 2 x 12 cm fiber bundle
• 15400556008697: everStick® PERIO 1 x 8 cm fiber bundle
• 15400556008680: everStick® ORTHO 2 x 12 cm fiber bundles
• 15400556008673: everStick® POST 5 x 2 post 1.5
• 15400556008666: everStick® POST 5x2 posts 1.2
• 15400556008659: everStick® POST 5 x 2 posts 0.9
• 15400556008598: everStick® PERIO 2 x 12 cm fiber bundles
• 15400556008550: everStick® NET 1 x 30 cm2 fiber mesh