Essix ACE® 1A478-50

GUDID D7461A478501

Essix ACE® Plastic - .040in 125mm Square

RAINTREE ESSIX INC.

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• Primary Device ID: D7461A478501
• NIH Device Record Key: 9f2dcb48-73a1-4a9b-b358-85f4b0969e82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Essix ACE®
• Version Model Number: 1A478-50
• Catalog Number: 1A478-50
• Company DUNS: 801157132
• Company Name: RAINTREE ESSIX INC.
• Device Count: 50
• DM Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7461A478500 [Unit of Use]
HIBCC	D7461A478501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062828

FDA Product Code

• NXC: Aligner, sequential

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-09-24

On-Brand Devices [Essix ACE®]

• D7461AH50PLAS1: Essix ACE® Plastic - .035in Vac 5" Square
• D7461AH50501: Essix ACE Plastic .035 x 125mm Square 50pk
• D7461AH501: Essix ACE Plastic .035 x Vacuum Square 100pk
• D7461AH347501: Essix ACE® Plastic - .035in 125mm Square
• D7461AH3471: Essix ACE Plastic - .035in 125mm Square 100pk
• D7461AH25SH1: Essix ACE® Plastic - .035in 125mm Circle Shinwon
• D7461AH25501: Essix ACE® Plastic - .035in 125mm Circle
• D7461AH251: Essix ACE Plastic 035 x 125mm Circle 100pk
• D7461AH20501: Essix ACE® Plastic - .035in 120mm Circle
• D7461A478501: Essix ACE® Plastic - .040in 125mm Square