Endosolv

Basic Information

• Brand Name: Endosolv
• Primary DI: 33760140704371
• Version / Model: 01E0400
• Catalog Number: 01E0400
• Company Name: SEPTODONT SAS SPECIALITES SEPTODONT
• Labeler DUNS: 275273795
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-06
• Public Version: 1
• Public Version Date: 2021-01-14
• Public Version Status: New
• Public Device Record Key: 53722f53-881a-4acf-a654-b5099f6dc5f1

Device Description

solvent for endodontic cements

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: 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
KIF	Resin, Root Canal Filling	Dental	872.3820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45234	Root canal filling-removal solution	A liquid substance used in endodontic procedures for the softening and removal of root canal fillings. It will typically be introduced into the root canal using instruments. The device typically contains solvents and other elements (e.g., tetra chloroethylene, formamide, eucalyptol, excipients). 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	33760140704371	GS1