3D Obturation Kit

Basic Information

• Brand Name: 3D Obturation Kit
• Primary DI: 00810092938675
• Version / Model: 63800012K
• Company Name: NUSMILE, LTD.
• Labeler DUNS: 185497372
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-11
• Public Version: 1
• Public Version Date: 2022-07-19
• Public Version Status: New
• Public Device Record Key: fb6a63ed-38bc-4109-9aab-af9c068d2019

Device Description

Z-UP System + Z-DOWN System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKR	Plugger, Root Canal, Endodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45247	Endodontic obturation system	An assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.	No	Active
45248	Endodontic obturation system generator	A mains electricity (AC-powered) device, which is part of an endodontic obturation system, intended to regulate the electrical current used to provide resistive heat for treatments involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. The energy generated by this device is conducted by using dedicated handpieces that can be attached to other dental instruments or used directly in the root canal.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810092938675	GS1

Customer Contacts

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