Essix ACE® 1AH25

GUDID D7461AH251

Essix ACE Plastic 035 x 125mm Circle 100pk

RAINTREE ESSIX INC.

Dental implant template, radiographic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic

• Primary Device ID: D7461AH251
• NIH Device Record Key: 1666c19c-d23c-4f07-90d3-0bc667c90301
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Essix ACE®
• Version Model Number: 1AH25
• Catalog Number: 1AH25
• Company DUNS: 801157132
• Company Name: RAINTREE ESSIX INC.
• Device Count: 100
• 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(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com
• Phone: +1(844)848-0137
• Email: essix.sales@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7461AH250 [Unit of Use]
HIBCC	D7461AH251 [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

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