Sonendo 17% EDTA

Basic Information

• Brand Name: Sonendo 17% EDTA
• Primary DI: 00858395006097
• Version / Model: FG-008-00001
• Catalog Number: GW-SYS-EDTA
• Company Name: SONENDO, INC.
• Labeler DUNS: 828894373
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9ee18f4e-4d3e-4359-952f-ab0cef0b6463

Device Description

Sonendo EDTA is a 17% EDTA chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin.

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• 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
EKL	Point, Silver, Endodontic	Dental	872.3840	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45233	Endodontic reaming aid material	A liquid or gel substance typically used during root canal procedures as a chelating agent for chemical reaming to aid mechanical reaming, or as a lubricant to facilitate endodontic instrument penetration. It will typically have bactericidal properties. 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	00858395006097	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K961089	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 27 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius