ESSIX C+® 1C500-BL

GUDID D7461C500BL1

Essix C+ plastic .040 square blue 25PK

RAINTREE ESSIX INC.

Dental implant template, radiographic

• Primary Device ID: D7461C500BL1
• NIH Device Record Key: bc51b618-cb1f-48cf-82b0-9efa6950e712
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESSIX C+®
• Version Model Number: 1C500-BL
• Catalog Number: 1C500-BL
• Company DUNS: 801157132
• Company Name: RAINTREE ESSIX INC.
• Device Count: 25
• 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	D7461C500BL0 [Unit of Use]
HIBCC	D7461C500BL1 [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 C+®]

• D7461C500YE1: ESSIX C+® Plastic - .040in Vac Sq - Yellow
• D7461C500TC1: Essix C+ plastic .040 square tooth 25PK
• D7461C500SH1: Essix C+ Plastic .040 x 5" Square 20PK
• D7461C500RD1: ESSIX C+® Plastic - .040in Vac Sq - Red
• D7461C500PLAS1: ESSIX C+® Plastic - .040in Vac 5" Sq
• D7461C500OC1: ESSIX C+® Plastic - .040in Square - Assort. Colors
• D7461C500GR1: ESSIX C+® Plastic - .040in Vac Sq - Green
• D7461C500BL1: Essix C+ plastic .040 square blue 25PK
• D7461C500501: Essix C+ Plastic .040 x 5" Square 50pk
• D7461C5001: Essix C+ Plastic .040 x 5" Square 100pk
• D7461C478501: ESSIX C+® Plastic - .040in 125mm Sq
• D7461C4781: Essix C+ Plastic .040 x 4.92" Square 100PK
• D7461C135501: ESSIX C+® Plastic - .040in 135mm Circle
• D7461C1351: ESSIX C+® Plastic - .040in 135mm Circle
• D7461C125YE1: Essix C+ .040 x 125mm circle yellow 25PK
• D7461C125TC1: ESSIX C+® Plastic - .040in 125mm Ci r- Tooth Color
• D7461C125SH1: Essix C+ Plastic .040 x 125mm Circle 20pk
• D7461C125RD1: Essix C+ Plastic .040 x 125mm circle red 25pk
• D7461C125OC1: ESSIX C+® Plastic - .040in 125mm Circle - Assort. C
• D7461C125GR1: Essix C+ Plastic .040 x 125mm circle green 25pk
• D7461C125BL1: Essix C+ Plastic .040 125mm circle blue 25PK
• D7461C125501: Essix C+ Plastic .040 x 125mm Circle 50pk
• D7461C1251: Essix C+ Plastic .040 x 125mm Circle 100pk
• D7461C120501: Essix C+ Plastic .040 x 120mm Circle 50pk
• D7461C1201: Essix C+ Plastic .040 x 120mm Circle 100PK