Essix®

Basic Information

• Brand Name: Essix®
• Primary DI: D746EUT6Y1
• Version / Model: EUT6-Y
• Catalog Number: EUT6-Y
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Labeler DUNS: 116903307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2023-11-21
• Public Version Status: Update
• Public Device Record Key: ec635971-c06f-4d8b-8991-3c84299587dc

Device Description

Upper Lateral - Tapered Pontic - Yellow Set of 6

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELM	Denture, plastic, teeth	Dental	872.3590	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44728	Dental shaded pontic kit	A collection of devices intended to be used to produce artificial tooth veneers (shaded pontics) typically inside clear plastic custom-made teeth aligners (retainer-style orthodontic appliances). This is used to create the appearance of teeth inside the aligner to cover spaces where teeth may be missing for aesthetic purposes during treatment to realign teeth. The contents of the device may include polymer-based materials, dispenser gun, mixing tips, applicator brushes and practice aligner.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D746EUT6Y1	HIBCC
Unit of Use	D746EUT6Y0	HIBCC

Customer Contacts

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