ImprEssix®

Basic Information

• Brand Name: ImprEssix®
• Primary DI: D746IE001201
• Version / Model: IE001-20
• Catalog Number: IE001-20
• Company Name: RAINTREE ESSIX INC.
• Labeler DUNS: 801157132
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2021-09-23
• Public Version Status: Update
• Public Device Record Key: 4c3a8077-926a-4c06-afc7-cbe20d5778b5
• Distribution End Date: 2021-02-19

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELW	MATERIAL, IMPRESSION	Dental	872.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35863	Alginate dental impression material	A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D746IE001201	HIBCC
Unit of Use	D746IE001200	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]