EDTA Plus

Basic Information

• Brand Name: EDTA Plus
• Primary DI: 00766054000112
• Version / Model: 770-02
• Catalog Number: 770-02
• 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: 5
• Public Version Date: 2020-05-06
• Public Version Status: Update
• Public Device Record Key: 5f4de7ad-6412-46c1-9d7e-3ef39dc9d88b

Device Description

Endodontic Irrigation Liquid for Removal of Smear Layer of Root Canal

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KJJ	CLEANSER, ROOT CANAL	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
45500	Root canal cleaning solution	A fluid or gel material intended to be used in dentistry to facilitate cleaning/irrigation of the root canal during/after endodontic instrumentation to remove the smear layer, pulpal tissue, necrotic materials, and bacteria from the root canal, before placement of the endodontic filling; it may also act as a lubricant to facilitate the passage of an instrument (e.g., file/rasp) into the root canal. It is typically available as a disinfecting solution (e.g., chlorhexidine, sodium hypochlorite solution) delivered into the canal with an irrigation needle, or similar device, providing mechanical and possibly chemical cleaning of the canal. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00766054000112	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072555	000

Device Sizes

Type	Value	Unit	Text
Total Volume	2	Fluid Ounce
Device Size Text, specify			One - 2 ounce bottle

Storage Conditions

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