EZ-Fill Xpress

Basic Information

• Brand Name: EZ-Fill Xpress
• Primary DI: 00766054000174
• Version / Model: 1625-00
• Catalog Number: 1625-00
• Company Name: ESSENTIAL DENTAL SYSTEMS, INC.
• Labeler DUNS: 101147171
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-01
• Public Version: 4
• Public Version Date: 2023-11-22
• Public Version Status: Update
• Public Device Record Key: bb4f9bcd-af5e-4ba9-b5e3-e44327a47d58

Device Description

Root Canal Xpress Cement Syringeable with Bi-Directional Spirals Nickel Titanium

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KIF	RESIN, ROOT CANAL FILLING	Dental	872.3820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60510	Hygroscopic dental cement	A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00766054000174	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K063856	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Two - 9.5 gram dual barrel syringes

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 60 – 85 Degrees Fahrenheit