everStick® 900831

GUDID 15400556008680

everStick® ORTHO 2 x 12 cm fiber bundles

Gc America Inc.

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