Tango-Endo

Basic Information

• Brand Name: Tango-Endo
• Primary DI: 00766054000709
• Version / Model: 5400-01
• Catalog Number: 5400-01
• Company Name: ESSENTIAL DENTAL SYSTEMS, INC.
• Labeler DUNS: 101147171
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-17
• Public Version: 2
• Public Version Date: 2022-10-19
• Public Version Status: Update
• Public Device Record Key: c8abb97f-56ee-4558-a57d-37677d202529
• Distribution End Date: 2022-10-01

Device Description

Tango-Endo Gutta Percha Points

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: Yes
• PM Exempt: Yes
• 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
EKM	GUTTA-PERCHA	Dental	872.3850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34791	Root canal obturating point	A metallic or polymeric based point or cone suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00766054000709	GS1

Customer Contacts

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