Essix 1MEDL120

GUDID D7461MEDL1201

3mm Essix Dual Laminate 120mm Circle

RAINTREE ESSIX INC.

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• Primary Device ID: D7461MEDL1201
• NIH Device Record Key: 40697a9e-5f09-4528-aa0d-1fa1592fefc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Essix
• Version Model Number: 1MEDL120
• Catalog Number: 1MEDL120
• 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	D7461MEDL1200 [Unit of Use]
HIBCC	D7461MEDL1201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062828

FDA Product Code

• MQC: Mouthguard, prescription

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

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• D746TUA6W1: Tapered Upper Anterior Pontic - White Set of 6
• D746TUA6G1: Tapered Upper Anterior Pontic - Gray Set of 6
• D74682PLAS1: Essix Plastics For Piers Kits
• D7461MENL1: Essix 3mm Niteguard Laminate Clear Square PK/12
• D7461MEDL1251: Essix 3mm x 125mm Dual Laminate Circle PK/12
• D7461MEDL1201: 3mm Essix Dual Laminate 120mm Circle
• D7461MEDL1: Essix 3mm Dual Laminate Square PK/12
• D746125001: Essix 2mm Dual Laminate Square PK/12
• D746121251: Essix 2mm x 125mm Dual Laminate Circle PK/12
• D746121201: 2mm Essix Dual Laminate 120mm CIR