EdgeCore for EdgeFile

Basic Information

• Brand Name: EdgeCore for EdgeFile
• Primary DI: 00819514025337
• Version / Model: X53008C
• Catalog Number: X53008C
• Company Name: US ENDODONTICS, LLC
• Labeler DUNS: 061317427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2023-04-25
• Public Version: 1
• Public Version Date: 2023-05-03
• Public Version Status: New
• Public Device Record Key: c3a50c5f-e5d4-4f9d-b22c-8edc5bd9213d

Device Description

Pink gutta percha core thermal obturator

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
47751	Warm-bonded endodontic obturation system obturator	A hand-held manual dental instrument designed for direct warm bonding during an endodontic obturation procedure. It is preloaded (encased) with a resin-based sealing, filling, and core material at its distal working end which is subsequently heated in a dedicated oven to a specified temperature prior to delivery of the materials into a root canal. It is available in a variety of root canal sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10819514025334	GS1
Primary	00819514025337	GS1

Customer Contacts

• Phone: [phone] ext. 103
• Email: [email protected]