ImprEssix® IE001

GUDID D746IE0011

Alginate dental impression material

Primary Device ID	D746IE0011
NIH Device Record Key	9498abc7-c440-4469-90fa-eaf1670f6f1e
Commercial Distribution Discontinuation	2021-02-22
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	ImprEssix®
Version Model Number	IE001
Catalog Number	IE001
Company DUNS	801157132
Company Name	RAINTREE ESSIX INC.
Device Count	1
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

Device Issuing Agency	Device ID
HIBCC	D746IE0011 [Primary]

ELW	MATERIAL, IMPRESSION

Steralize Prior To Use	false
Device Is Sterile	false

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

Mark Image Registration \| Serial	Company Trademark Application Date
IMPRESSIX 77081391 3441570 Live/Registered	DENTSPLY SIRONA ORTHODONTICS INC. 2007-01-11