ImprEssix® IE001-20

GUDID D746IE001201

ImprEssix® Alginate Xtra FastSet Case of 20, 500g bag

RAINTREE ESSIX INC.

Alginate dental impression material

• Primary Device ID: D746IE001201
• NIH Device Record Key: 4c3a8077-926a-4c06-afc7-cbe20d5778b5
• Commercial Distribution Discontinuation: 2021-02-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ImprEssix®
• Version Model Number: IE001-20
• Catalog Number: IE001-20
• Company DUNS: 801157132
• Company Name: RAINTREE ESSIX INC.
• Device Count: 20
• 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: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D746IE001200 [Unit of Use]
HIBCC	D746IE001201 [Primary]

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-09-23
• Device Publish Date: 2016-09-24

On-Brand Devices [ImprEssix®]

• D746IE0011: ImprEssix® Alginate Xtra Fast Set 500g bag
• D746IECCSAMP1: imprESSIX® Sample Pak
• D746IEC001SK1: ImprEssix® Color-Change Alginate Starter Kit
• D746IE001SK1: ImprEssix® Xtra Fast Set Alginate Starter Kit
• D746IE001201: ImprEssix® Alginate Xtra FastSet Case of 20, 500g bag
• D746IEC001201: ImprEssix® Color Change Alginate Case of 20, 500g
• D746IEC0011: ImprEssix® Color Change Alginate 500g bag